• Login / Signup
    • Instagram
    youtube
    Facebook

    Regulatory Affairs Associate

    Mint Pharmaceuticals
    0-1 years
    Not Disclosed
    12 April 9, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    About Mint Pharmaceuticals Inc.

    Canadian owned and operated, Mint Pharmaceuticals Inc. ("Mint") is a leading manufacturer of high quality and affordable generic pharmaceutical products. With a focus on consistent supply, innovation and exceptional customer service, Mint aims to deliver the highest value to patients across Canada. Mint has repeatedly been recognized as one of the leading generic companies in Canada and most reputable pharmaceutical companies in Canada. Since 2014, the company has averted 19 national drug shortages on 13 different drugs through its best-in-class supply chain management. The company was recognized by Deloitte and CIBC as one of Canada's Best Managed Businesses since 2019.

     

    JOB DESCRIPTION

     

    Position: Regulatory Affairs, Associate, India

    Reports to: Head of Regulatory Affairs, Corporate, Canada

    Location: India

     

    Primary Functions:

    We are currently seeking a self-motivated individual to join the Regulatory Affairs team. The successful candidate will be a critical team member responsible for preparation and submission of various regulatory submissions (primarily CMC documents) for new or marketed generic products to Australia, Europe, Health Canada, MHRA-UK, USFDA or external stakeholders. This is a remote position based in India and offers a great opportunity for professional development with an established and rapidly growing Canadian company.

     

    Roles and Responsibilities:

    • Manage and lead the team on New Generic Product Registrations, Labeling and Post approval submissions with Australia, Europe, Health Canada, MHRA-UK, USFDA. Work closely with leadership team at headquarters to ensure timely workflow and meeting of timelines.
    • Development and maintenance of excellent working relationships with global regulatory agencies, aiding in the potential reduction of filing requirements and timeliness of approvals, which significantly impact on the company’s competitive position within the industry.
    • Train fellow Associates on Regulatory due diligence, API selection pathway, submission strategies, CEP requirements, parameters impacting Drug Product formulation, Clinical studies overview and assisting them in career growth.
    • Perform gap analysis on dossiers to identify weakness and provide mitigation strategy for submission to regulatory Agencies.
    • Communication and coordination with partners/manufacturers to obtain supporting documents for ANDS submission. Giving scientific insight on New Product development and Technology Transfer Projects.
    • Responsible for assessing, coordinating and compiling deficiency responses in a timely manner to deficiency questions from Health Agencies.
    • Prepare product labelling and Patient Information Leaflet, as well as related items
    • Responsible for post-market product administration, participating in the review and evaluation of planned changes for impact on regulatory submissions, identifying regulatory filing requirements and recommending regulatory agency and customer notification strategies/plans in the affected regulatory jurisdictions.
    • Prepare SOP’s and work instructions, training programs on new regulatory guidelines, GMP, database management. Work closely with all functional groups (Canadian regulatory affairs, Business Development, Legal, Production, Quality, R&D) within and outside (manufacturing partners) the company to ensure all regulatory obligations are met.
    • Manage collaborations with external partner sites for new projects. Serve as main point of contact with third-party manufacturers for the projects led.
    • Maintain awareness of current regulatory environment and guidelines that impact the organization and share knowledge with internal stakeholders, as required.
    • Remain up to date on applicable regulatory guidelines (global regulatory, ICH, etc.).

     

    Major Tasks:

     

    Submissions

    • Review dossiers shared by partner companies for global regulatory submissions for completeness, accuracy and compliance with regulatory requirements and providing feedback to partners.
    • Review Drug Master Files and provide gap assessments to partners.
    • Preparation of global regulatory submissions (CTD format) including compiling, writing, and publishing
    • Timely preparation and filing of submissions to support company needs.

     

     

    New Product Assessments/ Product Launches

    • Monitoring product development activities by interacting contract developers and manufacturers as necessary against identified submission targets.
    • Provide impact regarding formulation of drug development, clinical development etc. Initiation of Change Controls for changes from submission documents to launch documents, for handover to Quality Department.

     

    Bioequivalence Studies

    • Coordination and Support with CRO as needed for global BE studies.

     

    Labelling

    • Review and approve artwork routings of labelling.

     

    Compliance

    • Ensure continual regulatory compliance of all products due to changes initiated from regulatory agencies (e.g. Labeling, Quality, changes)
    • Help to develop and oversee procedures and processes within Regulatory Operating Procedures to ensure compliance applicable regulations (e.g. Working Instructions are up to date, SOPS are followed etc.)
    • Assist in development and maintenance of accurate databases
    • Oversee the timely preparation of activities for other functional groups (SAP codes creations, launch documentation packages

     

    Skills & Qualifications:

    • Bachelor of Science (or higher) in Biological Sciences, Pharmacology, Toxicology, Chemistry or related Health Sciences
    • 6-8 years of experience in the regulatory affairs field
    • Must have strong technical knowledge of CMC requirements and is able to critically analyze scientific data.
    • Strong knowledge of CTD requirements for global drug submissions.
    • Strong hands-on experience with writing sections of the CTD (with focus on CMC)
    • Knowledge of electronic submissions, including e-publishing (e.g., Docubridge)
    • Strong interpersonal skills and ability to foster strong working relationships with key stakeholders (internally and externally)
    • Strong working knowledge of global regulatory, Food and Drug Regulations, GMPs, ICH Guidelines
    • Ability to prioritize workload to ensure all deadlines are met
    • Excellent organization, written and oral communication skills
    • Ability to effectively manage multiple projects in a fast-paced, results oriented environment
    • Strong commitment to quality, accuracy, and detail
    • Ability to work well under pressure in a team-based environment

    Latest Jobs

    Drug Safety Associate I

    Parexel
    Mohali

    Pharmacovigilance Reporting Associate

    Icon
    Chennai

    Executive - Voice/Non Voice- Bhopal

    Hexaware Technologies
    Bhopal

    Pharmacovigilance Services Specialist

    Accenture
    Bengaluru

    Pharmacovigilance Services Specialist

    Accenture
    Bengaluru

    Pharmacovigilance Reporting Associate

    Icon
    Remote

    Medical Information Specialist

    Eversana
    Pune

    Medical Information Specialist

    Eversana
    Pune

    Serialization Analyst

    Eversana
    Pune

    Medical Reviewer

    Eversana
    Remote

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Eot Municipality | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji | Verna |

    Gujarat :

    Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    India :

    Siliguri |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |

    Maharashtra :

    Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |

    Odisha :

    Bhubaneswar | Rourkela |

    PAN-India :

    Panjab :

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |

    Sikkim :

    Rangpo |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |

    Albama :

    Tuscaloosa |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |

    Arkansas :

    Fort Smith |

    California :

    Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | Temecula | Thousand Oaks | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Bridgeport | Bristol | Enfield | Groton | Newtown | South Windsor | Storrs | West Hartford |

    D.C :

    Washington |

    Delaware :

    Wilmington |

    Florida :

    Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Jacksonville | Maitland | Miami | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta | Rome |

    Hawaii :

    Hilo | Honolulu |

    Idaho :

    Boise |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Garden city | Lawrence | McPherson |

    Kenlucky :

    Louisville | Shelbyville |

    Kington :

    Frank Scottile Blvd |

    LA :

    Baton Rouge | Monroe | New Orleans |

    Louisiana :

    Lake Charles | Shreveport |

    Maine :

    Bangor | Brewer |

    Maryland :

    Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro |

    Massachusetts :

    Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |

    Michigan :

    Detroit | Houghton Lake |

    Minnesota :

    Duluth | Eden Prairie | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |

    Missouri :

    Fulton | Milan | St. Louis |

    Nebraska :

    Hebron | Nebraska City |

    Nevada :

    Las Vegas | Tonopah | Tonopsh |

    New Hampshire :

    Lebanon | Manchester |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New Mexico :

    Farmington | Santa Fe | Tucumcari |

    New York :

    Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |

    North Carolina :

    Concord | Lumberton | North Carolina |

    North Caroline :

    Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |

    North Dakota :

    Dickinson |

    northeastern :

    New Hampshire |

    Ohio :

    Cincinnati | Cleveland | Columbus, | Dayton | Erie | Macedonia | oxford | Waynesville |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Coquille | Corvallis | Eugene | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |

    Pennsylvania :

    Ambler | Collegeville | Harrisburg | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Spring House | West Chester | Wyomissing |

    Portugal :

    Lisbon | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Memphis | Nashville |

    Texas :

    Abilene | Arlington | Austin | Brenham | Bulverde | Corpus Christi | Corsicana | Dallas | Fort Worth | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Tyler | Waco |

    United states :

    fairmont | Georgia | United States |

    United States :

    Hawai | Sylmar |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Bellevue | Bothell | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Vancouver |

    WI :

    Madison | Wausau |

    Wisconsin :

    Portage |

    Wyoming :

    Big Piney | Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Germany :

    Germany | GErmany |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Ingelheim am Rhein | Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    BULGARIA :

    Bulgaria |

    Denmark :

    Copenhagen | Denmark |

    Europe :

    Latvia | Leuven | Poland | Spain |

    Finland :

    Finland |

    Hungary :

    Budapest |

    Istanbul :

    Istanbul | Turkey |

    Norway :

    Norway | NOrway |

    Romania :

    Romania |

    Serbia :

    Belgrade | Serbia |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    China :

    China |

    Hubei :

    Wuhan |

    Liaoning :

    Dalian |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Zhejiang :

    Hangzhou |

    Pharma Jobs in Ireland

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Dún Laoghaire :

    Dún Laoghaire |

    Republic of Ireland :

    Dublin | Limerick | Waterford |

    Ulster :

    Donegal |

    Pharma Jobs in Australia

    New South Wales :

    Ballina | Sydney |

    Queensland :

    Queensland |

    Remote Australia :

    Remote Australia |

    Republic of Western Australia :

    Nedlands |

    Pharma Jobs in Netherland

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    South Holland :

    Leiden |

    Pharma Jobs in United Kingdom

    Antrim :

    Larne |

    Cheshire :

    Runcorn |

    Hertfordshire :

    Welwyn |

    Surrey :

    Pirbright |

    Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

    Buenos Aires :

    Buenos Aires |

    Austria :

    Austria |

    Vienna :

    Vienna |

    Antwerp :

    Heist op den Berg |

    Brussels :

    Brussels |

    Bosnia and Herzegovina :

    Sarajevo |

    Sofia City :

    Sofia |

    Canada :

    Canada |

    Ontario :

    North York | Mississauga | Uxbridge | Richmond Hill |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Croatia :

    Croatia |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    South Yorkshire :

    Sheffield |

    United Kingdom :

    Maidenhead | London | Stirling | United Kingdom | Harlow | Salt Lake City | Leeds |

    Estonia :

    Tartu | Estonia |

    Harju County (Maakond) :

    Tallinn |

    Chuuk :

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Paris | Lyon |

    Attica :

    Athens | Koropi |

    Greece :

    Greece |

    East Java :

    Surabaya |

    Jakarta :

    Jakarta |

    Israel :

    Be'Er Sheva | Kfar Saba | Netanya | Tel Aviv |

    Italy :

    Italy |

    Lombardy :

    Rho |

    Japan :

    Japan |

    Tokyo :

    Otemachi |

    Kazakhstan :

    Almaty |

    Remote Korea :

    Remote Korea |

    Republic of Korea :

    Seoul |

    Kuala Lumpur :

    Kuala Lumpur |

    Mexico :

    Ciudad de México |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

    Remote, USA | Remote - Middle East | Remote - Europe | Remote | Switzerland |

    Bucharest :

    Bucharest |

    Makkah :

    King Abdullah Economic City | Riyadh | Rabigh | Jeddah | Najran | Khulais |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand |

    Brazil :

    Sao paulo |

    South America :

    Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |