• Login / Signup
    • Instagram
    youtube
    Facebook

    Senior Regulatory Affairs Associate-Biologics

    Parexel
    4-8 years
    Preferred by Comapny
    Bengaluru
    10 Nov. 25, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Regulatory Affairs Associate

    Job Description:

    We are looking for a Senior Regulatory Affairs Associate with 4-8 years of experience in the pre- and post-approval lifecycle management of drug products, including small molecules and biologics, across various markets. The ideal candidate will have experience in regulatory frameworks and a solid understanding of global pharmaceutical legislation and regulatory CMC (Chemistry, Manufacturing, and Controls) aspects.

    This role requires a strong background in EU/US regulatory procedures, with knowledge of ROW (Rest of World)markets being a bonus, and the ability to manage complex regulatory submissions and variations.

    Key Responsibilities:

    1. Regulatory Lifecycle Management:

      • Manage pre- and post-approval lifecycle for drug products (small molecules and biologics) across global markets.
      • Contribute to regulatory submissions, from simpler to more complex submissions, in alignment with global and regional regulatory requirements.

    2. Regulatory Submissions:

      • Preparation and review of Marketing Authorization Applications (MAAs) and variations for medicinal products (Orals & Parenterals) in the EU through various procedures like DCP, MRP, and National Procedures.
      • Handle documentation for Variation procedures such as Super grouping, Grouping, and Work-sharingto Marketing Authorizations.
      • Prepare and submit safety variations to Health Authorities and perform post-approval CMC-related updates.

    3. Regulatory CMC and Compliance:

      • Manage CMC-related health authority queries and ensure compliance of DMFs, batch records, specifications, and stability data with regulatory requirements.
      • Perform regulatory impact assessments for change proposals and identify the required documentation for EU submissions.
      • Liaise with cross-functional teams to ensure compliance with regulatory standards and submission requirements.

    4. Coordination & Stakeholder Management:

      • Work closely with internal and external teams to ensure effective submission delivery plans and manage submission content plans.
      • Provide regular status updates to stakeholders regarding submission progress.

    5. Regulatory Information Systems:

      • Utilize Regulatory Information Management Systems (e.g., Veeva Vault) for efficient tracking and submission of regulatory documents.

    6. Team Mentorship & Communication:

      • Provide guidance and mentorship to junior team members.
      • Demonstrate strong communication skills in coordinating with internal teams, stakeholders, and Health Authorities.

    7. Regulatory Strategy & Planning:

      • Lead or assist in regulatory strategy discussions and contribute to overall product development goals by aligning with regulatory trends and requirements across regions.

    Required Skills & Qualifications:

    • Experience: 4-8 years of relevant experience in regulatory affairs, specifically in the life cycle management of small molecules and biologics.
    • Regulatory Knowledge: Solid understanding of EU and US regulatory procedures, including post-approval requirements. Knowledge of ROW markets is a plus.
    • CMC Expertise: Experience handling CMC-related health authority queries, and preparing and reviewing DMFs, batch records, specifications, and stability data.
    • Documentation & Variations: Proven experience in preparing Marketing Authorization Applications (MAA)and variations (including super grouping and work-sharing procedures).
    • Information Management: Familiarity with Regulatory Information Management Systems, such as Veeva Vault.
    • Teamwork & Mentorship: Strong communication and collaboration skills, with the ability to mentor junior staff and work cross-functionally.
    • Autonomy: Ability to work independently and manage complex regulatory tasks and submissions.

    Desired Skills:

    • Knowledge of global pharmaceutical legislation and ICH regulations related to regulatory CMC aspects.
    • Experience in regulatory review of complex data (e.g., stability data, batch records, specifications).
    • Ability to handle and resolve regulatory impact assessments for changes.

    This position offers a chance to lead regulatory affairs efforts within a dynamic team, contributing to both the pre-market approval and post-market maintenance of drug products, ensuring their compliance with global regulatory standards.

    Latest Jobs

    Clinical Associate

    Abbott
    Shreveport

    Senior R&D Manager

    Abbott
    Menlo Park

    Ehr Connectivity Ops Application Analyst

    Abbott
    St.Paul

    Senior Facilities Technician

    Abbott
    St.Paul

    Clinical Specialist, Cpt - New York

    Abbott
    New York

    Clinical Specialist I, Cpt – San Antonio, Tx

    Abbott
    San Antonio

    Clinical Specialist I, Cpt - Salem, Or

    Abbott
    Salem

    Head Of Medical Affairs, Greater China

    Abbott
    Shanghai Shi

    Senior Clinical Project Specialist - Structural Heart

    Abbott
    Minneapolis and St. Paul, Minnesota. Plano Sylmar

    Medical Affairs Manager

    Abbott
    Almaty

    Pharma Jobs in India

    Andra Pradesh :

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

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

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

    Haryana :

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

    Himachal Pradesh :

    Solan |

    India :

    Siliguri |

    Jharkhand :

    Ranchi |

    Karnataka :

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

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |

    Maharashtra :

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

    PAN-India :

    Panjab :

    Punjab :

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

    Rajasthan :

    Banasthali | Jaipur | Pilani | Udaipur |

    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 | Wrangell |

    Arizona :

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

    Arkansas :

    Fort Smith |

    California :

    Alameda | Brisbane | California | Crescent City | Davis | El Monte | El Segundo | Emeryville | Foster City | Fremont | Glendale | Irvine | La Jolla | Los Angeles | Martinez | Menlo Park | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | 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 | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Bridgeport | Enfield | Groton | Storrs |

    D.C :

    Washington |

    Florida :

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

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

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

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Garden city | Lawrence |

    Kenlucky :

    Shelbyville |

    Kington :

    Frank Scottile Blvd |

    LA :

    Monroe | New Orleans |

    Louisiana :

    Lake Charles | Shreveport |

    Maryland :

    Baltimore | Elkridge | Gaithersburg | Rockville |

    Massachusetts :

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

    Michigan :

    Detroit | Houghton Lake |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. | St.Paul |

    Missouri :

    Fulton | St. Louis |

    Nevada :

    Las Vegas |

    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 :

    Santa Fe |

    New York :

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

    North Carolina :

    Concord | Lumberton | North Carolina |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Sanford | Scottsdale |

    North Dakota :

    Dickinson |

    Ohio :

    Cincinnati | Cleveland | Columbus, | Macedonia |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Salem | Springfield |

    Pennsylvania :

    Ambler | Collegeville | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |

    Portugal :

    Lisbon | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Nashville |

    Texas :

    Abilene | Austin | Bulverde | Corsicana | Dallas | Houston | Longview | Plano | Richardson | San Antonio | Tyler | Waco |

    United states :

    Georgia | United States |

    United States :

    Hawai | Sylmar |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Bothell | Goldendale | Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Wyoming :

    Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    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 :

    Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    BULGARIA :

    Bulgaria |

    Denmark :

    Copenhagen |

    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

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Pharma Jobs in Argentina & Australia & Belgium & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Finland & France & Indonesia & Ireland & Israel & Japan & Kazakhstan & Korea & Netherland & Philippines & Portugal & Remote & Saudi Arabia & Singapore & South America & Spain & Taiwan & Tennessee & Thailand & Turkey & United Arab Emirates

    Buenos Aires :

    Buenos Aires |

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Antwerp :

    Heist op den Berg |

    Brussels :

    Brussels |

    Canada :

    Canada |

    Ontario :

    Richmond Hill | North York |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    United Kingdom :

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

    Estonia :

    Estonia |

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Paris | Lyon |

    Jakarta :

    Jakarta |

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Republic of Ireland :

    Waterford | Dublin | Limerick |

    Israel :

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

    Tokyo :

    Otemachi |

    Kazakhstan :

    Almaty |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    Philippines :

    Manila |

    Remote :

    Remote | Switzerland | Remote - Europe | Remote, USA |

    Makkah :

    Riyadh | Jeddah | Najran | Khulais | Rabigh |

    Singapore :

    Singapore |

    Brazil :

    Sao paulo |

    South America :

    Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Dubai :

    Dubai |