Senior Regulatory Associate
Location: Guadalajara, Jalisco, Mexico
Date Posted: April 16, 2025
About the Role:
Indegene is seeking a Senior Regulatory Associate to join our expanding team. This role involves preparing and managing regulatory dossiers, coordinating with regulatory authorities for EU and ASEAN markets, and providing regulatory guidance to internal teams. With Indegene's dynamic, technology-driven environment, this is an excellent opportunity to accelerate your career in the healthcare and technology space.
Key Responsibilities:
Regulatory Dossier Preparation & Submission:
Prepare and manage regulatory dossiers, ensuring compliance with EU and ASEAN regulatory frameworks.
Coordinate with regulatory authorities for initial submission, licensing, and post-approval submissions.
Cross-Functional Collaboration & Communication:
Organize and lead cross-functional meetings with stakeholders.
Collaborate with teams such as R&D, quality assurance, and manufacturing to gather necessary information for regulatory submissions.
Regulatory Knowledge & Documentation:
Demonstrate thorough knowledge of EU and ASEAN regulatory procedures for various types of applications.
Prepare and support Module 1 documents for regulatory submissions, including submission forms, cover letters, and comparison tables.
Quality Control & Risk Management:
Review the content prepared by junior team members and ensure the authenticity of the content through QC.
Identify regulatory risks and propose mitigation strategies.
Regulatory Intelligence & Knowledge Sharing:
Extract regulatory intelligence information for various registration types (CTA, drug/device/cosmetic/food).
Provide coaching, mentoring, and knowledge sharing within the regulatory team.
Regulatory Documentation Systems & Publishing:
Hands-on experience with regulatory document management systems and publishing tools.
Track submission components and coordinate publishing activities with the publishing team.
Training & Mentoring:
Mentor new joiners on SOPs and processes.
Volunteer in training programs to enhance skills and knowledge in relevant areas.
Required Qualifications:
Education: BPharm, MPharm, Pharm D, or MSc.
Experience: 4-6 years of experience in EU/ASEAN markets.
Skills:
Strong communication skills (written and oral).
Proficiency in MS Office (Excel, PowerPoint) and Adobe Professional.
Experience with regulatory document management systems and publishing tools, ideally RIMS (Veeva Vault, Trackwise).
Desired Qualifications:
Hands-on experience in regulatory submission formats and regulatory affairs procedures.
Ability to extract regulatory intelligence information and understand various registration requirements.
Strong mentoring skills and ability to lead cross-functional projects.
Equal Opportunity Statement:
Indegene is committed to fostering an inclusive and diverse workplace. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristic. All employment decisions are made based on business needs, the candidate’s qualifications, and merit.
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Digha | Kolkata | Mukundapur |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 :
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Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Wilmington |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | 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 | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
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Hilo | Honolulu |Idaho :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |New Jersey :
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Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
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China | Quarry Bay |Hubei :
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Beijing |Shanghai Sai :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Haarlem |North Brabant :
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Leiden |North Yorkshire :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Renfrew | Richmond Hill | Uxbridge | Mississauga | North York |Quebec :
Montreal |Chile :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
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Turku |France :
Paris | Lyon |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Be'Er Sheva | Kfar Saba | Tel Aviv | Netanya | Yavne |Italy :
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Warsaw |Remote :
McFarland | Remote - Africa | Remote - Europe | Melbourne | Lenexa | Remote - Middle East | Remote, USA | Victoria | Remote - South America (Latin Americal) | Remote | Switzerland |Bucharest :
Bucharest |Makkah :
Jeddah | King Abdullah Economic City | Riyadh | Najran | Rabigh | Khulais |Nišava District :
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Sweden |Taipei :
Taipei |Williamson :
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