Position: Senior Associate – CMC5
Location: Bengaluru, India
Job Summary:
The Senior Associate – CMC5 will be responsible for authoring and managing Chemistry, Manufacturing, and Controls (CMC) documentation (Modules 2 & 3), coordinating product lifecycle management, and ensuring compliance with regional regulatory requirements (EU & CIS). The role involves preparing and submitting regulatory dossiers, supporting product registrations, and maintaining effective communication with internal stakeholders and health authorities.
Key Responsibilities:
Regulatory Documentation & Submissions
Prepare and submit new product registrations and post-approval submissions.
Draft and review CMC modules (Module 2 and Module 3) for regulatory filings.
Support timely responses to queries and follow-ups until approval.
Manage eCTD submissions for EU and CIS markets.
Product Lifecycle & Compliance
Coordinate and manage product lifecycle activities to ensure continuous compliance.
Maintain regulatory compliance with local and international regulatory requirements.
Execute regulatory strategies aligned with business objectives and local regulations.
Ensure adherence to defined timelines and quality parameters.
Cross-functional Collaboration
Build and maintain strong professional relationships with health authorities and internal stakeholders.
Provide regulatory support for new product launches, tender applications, and line extensions.
Promote regulatory intelligence and process improvements within the team.
Documentation & Labeling
Review formulation data and generate ingredient lists and claims as per standards.
Compile and review labeling components in accordance with SOPs.
Maintain and update regulatory work processes, documentation, and tracking tools.
Qualifications & Skills:
Education:
Bachelor’s degree in Chemistry, Pharmacy, or a related scientific field.
Experience:
Proven experience in CMC Regulatory Affairs for pharmaceutical products.
Hands-on experience with Module 3, Module 2.3, and Module 1 (eCTD) documentation.
Exposure to EU and CIS regulatory requirements and guidelines.
Core Competencies:
Excellent project management and multitasking skills.
Strong attention to detail and accuracy.
Effective written and verbal communication.
Ability to work independently and remotely with minimal supervision.
Familiarity with EU pharmaceutical guidelines and regulatory interpretation.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bhubaneswar | Rourkela |Chhattisgarh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Uxbridge | North York | Australia | Richmond Hill | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Bangkok |Israel :
Yavne | Kfar Saba | Be'Er Sheva | Netanya | Tel Aviv |Remote :
Belgium | Remote - South America (Latin Americal) | Slovakia | Blue Bell | Medan | Victoria | Hungary | Remote, USA | Nairobi | Bishop | Zaragoza | Leinster | Regulatory Labeling Manager (NA and LATAM Only) | Faridabad | Green Way | Lousiana | Thailand | Bountiful | Switzerland | Remote - Europe | Ireland | Xzagreb | McFarland | Hammond | French | Remote - Middle East | Texas | Tulsa | Castlebar | Remote - Africa | Minnesota | Remote | Springville | Melbourne | Manipal | Riga | Lenexa |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
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Riyadh | Najran | Rabigh | Khulais | Jeddah | King Abdullah Economic City |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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