Executive/Senior Executive – Global Regulatory Affairs (RA)
Location: Pune, Maharashtra, India | Employee Type: Permanent | Department: Global CMC-RA
Company Overview:
Join a leading biopharmaceutical organization at the forefront of global regulatory compliance and submissions. The Global RA team ensures timely and high-quality submissions to regulatory authorities while supporting product development and lifecycle management.
Role Overview:
We are seeking an Executive/Senior Executive – Global RA with strong expertise in Chemistry, Manufacturing, and Controls (CMC) regulatory submissions. The role involves preparing, reviewing, and finalizing regulatory documents for US (FDA) and European (EMA) authorities, ensuring compliance with ICH and regional guidelines.
Key Responsibilities:
Review, finalize, and compile CMC documents for US (FDA) and European (EMA) regulatory submissions.
Draft, compile, and review eCTD sections, ensuring adherence to current regulatory and technical standards.
Author and review critical regulatory documents, including INDs, IMPDs, and Briefing Books (BBs).
Collaborate effectively with cross-functional teams (Quality, Manufacturing, Analytical, Clinical) to gather necessary information and align on submission strategy.
Ensure appropriate regulatory language and consistency across all submission documents.
Verify compliance with PDF publishing and technical property requirements for eCTD submissions.
Maintain up-to-date knowledge of ICH guidelines, regional regulatory frameworks, and biosimilar-specific requirements.
Support regulatory strategy development and respond to health authority queries as needed.
Qualifications & Experience:
Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Life Sciences, or related field.
4–7 years of experience in regulatory affairs, preferably with exposure to global CMC submissions.
Hands-on experience with eCTD compilation, submission formatting, and document management.
Strong understanding of FDA, EMA, and ICH guidelines.
Skills & Competencies:
Excellent written and verbal communication skills.
Strong attention to detail and organizational abilities.
Ability to collaborate across multiple functions and maintain compliance under deadlines.
Analytical mindset with problem-solving capabilities.
Why Join Us:
This role offers exposure to global regulatory submissions, cross-functional collaboration, and opportunities to contribute to regulatory strategy development in a dynamic biopharmaceutical environment.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Donegal |Meath :
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Canada |Quebec :
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Brussels |Antwerp :
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Greece |North Island :
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Manila |Croatia :
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Zagreb |Estonia :
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