• Login / Signup
    • Instagram
    youtube
    Facebook

    Associate Director - Regulatory Affairs And Liaisoning

    Eli Lily
    8+ years
    Not Disclosed
    Gurgaon
    10 Jan. 29, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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: Associate Director - Regulatory Affairs and Liaisoning
    Location: Gurgaon, Haryana, India
    Category: Research & Development
    Job Type: Full-Time, Regular
    Job ID: R-72431

    About Eli Lilly:

    At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our employees work to discover and deliver life-changing medicines. We also focus on improving the understanding and management of disease, alongside philanthropy and community service. Our commitment to making life better for patients around the world is at the heart of everything we do.

    Job Summary:

    The Associate Director - Regulatory Affairs and Liaisoning will manage and coordinate regulatory activities with key regulatory bodies in India. This includes liaising with the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare (MoHFW), National Institute of Biologicals (NIB), Indian Pharmacopoeia Commission (IPC), and other relevant government authorities at both central and state levels. The role is responsible for ensuring compliance with local regulations, facilitating effective communication with regulatory bodies, and supporting the registration and maintenance of pharmaceutical products.

    Key Responsibilities:

    • Regulatory Compliance: Ensure all regulatory activities adhere to local regulations and guidelines set by CDSCO, MoHFW, NIB, IPC Ghaziabad, CDTL, and other authorities.
    • Liaison with Regulatory Bodies: Act as the primary point of contact between the company and regulatory authorities, ensuring smooth communication and addressing regulatory queries or issues.
    • Product Registration: Oversee the registration process for new products, line extensions, and new indications, ensuring timely submission and approval of regulatory dossiers.
    • Documentation: Prepare, review, and submit regulatory documents, including applications, variations, renewals, and responses to regulatory authorities.
    • Regulatory Strategy: Develop and implement regulatory strategies to support the company’s business objectives and ensure successful product registrations.
    • Cross-functional Collaboration: Work closely with internal departments, including R&D, Quality Assurance, and Marketing, to ensure alignment on regulatory requirements and timelines.
    • Regulatory Intelligence: Monitor and analyze changes in regulatory policies and guidelines, providing updates and recommendations to the management team, and maintaining related repositories.
    • Training and Development: Provide training and guidance to internal teams on regulatory requirements and best practices.
    • Stakeholder Management: Build and maintain relationships with key stakeholders, including government officials, industry associations, and other relevant entities.
    • Risk Management: Identify potential regulatory risks and develop strategies to mitigate those risks, ensuring compliance and minimizing operational impact.

    Qualifications:

    • Education: Bachelor’s degree in Pharmacy, Life Sciences, or a related field. Advanced degree preferred.
    • Experience: Minimum of 8 years of experience in regulatory affairs within the pharmaceutical industry, preferably in a multinational corporation (MNC).
    • Knowledge: In-depth knowledge of Indian regulatory requirements and guidelines, particularly those of CDSCO, MoHFW, NIB, IPC Ghaziabad, CDTL, and other relevant authorities.
    • Skills:
      • Strong communication and interpersonal skills, with the ability to build and maintain relationships with regulatory authorities.
      • Excellent organizational and project management skills, with the ability to manage multiple tasks and deadlines.
      • Proficiency in regulatory documentation and submission processes.

    Preferred Skills:

    • Experience in regulatory liaison roles or similar positions.
    • Familiarity with global regulatory requirements and guidelines.
    • Strong analytical and problem-solving skills.
    • Ability to work independently and as part of a team.

    Why Join Us?

    Lilly is committed to creating an inclusive workplace, where all employees feel valued and respected. We offer a comprehensive benefits package, along with opportunities for career development and growth.

    Equal Opportunity:

    Lilly is dedicated to ensuring equal opportunities for individuals with disabilities. If you require accommodation to submit a resume, please complete the accommodation request form here.

    Lilly is an Equal Employment Opportunity/Affirmative Action Employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

    #WeAreLilly

    Latest Jobs

    Quality-Medical Affairs Professional

    Lilly
    Bangalore India

    Medical Writing – Medical Affairs

    Lilly
    Bangalore India

    Quality Medical Reviewer – Medical Affairs Quality

    Lilly
    Bangalore India

    Specialist - Medical Editor

    Lilly
    Bangalore India

    Specialist - Quality Operations (Gqs I)

    Sandoz
    India Remote

    Patient Safety Specialist

    Sandoz
    India Remote

    Global Medical Development Manager

    Sandoz
    India Remote

    Patient Safety Specialist

    Sandoz
    India Remote

    Senior Clinical Research Associate

    Advanced Clinic
    Deerfield United States

    Senior Clinical Data Associate

    Advanced Clinic
    Ahmedabad India

    Pharma Jobs in India

    Andra Pradesh :

    Anakapali | 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 | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

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

    Himachal Pradesh :

    Baddi | Solan |

    India :

    Siliguri |

    Jharkhand :

    Ranchi |

    Karnataka :

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

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |

    Madhya Pradesh :

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

    Maharashtra :

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

    Odisha :

    Bhubaneswar | Rourkela |

    PAN-India :

    Panjab :

    Pondicherry (Puducherry) :

    Pondicherry (Puducherry) |

    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 | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

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

    Uttarakhand :

    Dehradun | Nainital | Rishikesh | Roorkee |

    West Bengal :

    Digha | Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

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

    Albama :

    Tuscaloosa |

    Arizona :

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

    Arkansas :

    Fort Smith |

    California :

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

    Colorado :

    Boulder | Denver | Westminster |

    Connecticut :

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

    D.C :

    Washington |

    Delaware :

    Wilmington |

    Florida :

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

    Georgia :

    Atlanta | Rome |

    Hawaii :

    Hilo | Honolulu |

    Idaho :

    Boise |

    Illinois :

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

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Garden city | Kansas City | Lawrence | McPherson |

    Kentucky :

    Edgewood | Ft MItchell | 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 | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |

    Missouri :

    Fulton | Milan | St. Louis |

    Nebraska :

    Hebron | Nebraska City |

    Nevada :

    Las Vegas | Tonopah | Tonopsh | Virginia |

    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 | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | 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 | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |

    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 :

    Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Norwood | Oregoina | oxford | Waynesville |

    Oklahoma :

    Oklahoma City |

    Oregon :

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

    Pennsylvania :

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

    Portugal :

    Lisbon | Oeiras | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Memphis | Nashville |

    Texas :

    Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |

    United states :

    fairmont | Georgia | OH | United States |

    United States :

    Hawai | kentucky | Sylmar | Woonsocket |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Bellevue | Bothell | Friday Harbor | 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 :

    Darmstadt | Marburg |

    Hessen :

    Frankfurt | Harveysburg |

    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

    Belgium :

    Wavre |

    BULGARIA :

    Bulgaria |

    Denmark :

    Copenhagen | Denmark |

    Europe :

    France | Latvia | Lendava | Leuven | Poland | Slovenia | 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 | Quarry Bay |

    Hubei :

    Wuhan |

    Liaoning :

    Dalian |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Zhejiang :

    Hangzhou |

    Pharma Jobs in Australia

    Melbourne :

    South Yarra |

    New South Wales :

    Ballina | Sydney |

    Queensland :

    Queensland |

    Remote Australia :

    Remote Australia |

    Republic of Western Australia :

    Nedlands |

    Pharma Jobs in Ireland

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Dún Laoghaire :

    Dún Laoghaire |

    Republic of Ireland :

    Cork | Dublin | Limerick | Waterford |

    Ulster :

    Donegal |

    Pharma Jobs in Netherland

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    North Brabant :

    Breda |

    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 & New Zealand & Peru & 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 |

    Flemish Brabant :

    Zaventem |

    Bosnia and Herzegovina :

    Sarajevo |

    Sofia City :

    Sofia |

    Canada :

    Canada |

    Ontario :

    North York | Renfrew | Mississauga | Richmond Hill | Uxbridge |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Croatia :

    Croatia |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    Oxfordshire :

    Witney |

    South Yorkshire :

    Sheffield |

    United Kingdom :

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

    Estonia :

    Tartu | Estonia |

    Harju County (Maakond) :

    Tallinn |

    Chuuk :

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Paris | Lyon |

    Attica :

    Koropi | Athens |

    Greece :

    Greece |

    East Java :

    Surabaya |

    Jakarta :

    Jakarta |

    Israel :

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

    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 |

    North Island :

    Auckland |

    Lima Region :

    Lima |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

    Remote | Remote - Europe | Remote - Africa | Remote - South America (Latin Americal) | Remote, USA | Switzerland | Remote - Middle East |

    Bucharest :

    Bucharest |

    Makkah :

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

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Peru | 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 |