Senior Regulatory Affairs Specialist

Job Title:

CMC Biologics Consultant

Location:

India (Fully Remote)
Requirement:  Consulting Experience
Work Model:  Fully Remote
Contract Period:  1 Year

Company Overview:
Apsida Life Science has partnered with a leading global Clinical Research Organisation (CRO) renowned for its scientifically driven programs. They specialise in managing complex Phase I–IV trials across diverse therapeutic areas for innovative biotechnology and pharmaceutical firms worldwide.

The Opportunity:

Act as the primary CMC lead, taking full responsibility for biologics product lifecycle management, including submission strategies for variations.
Coordinate and oversee the submission of variations, renewals, annual reports, and responses to deficiency letters.
Lead Module 3 (M3) authoring and review to ensure internal consistency and alignment with global regulatory guidelines.
Conduct comprehensive assessments of change controls to determine their impact on existing regulatory submissions.
Collaborate with R&D, Manufacturing, and Quality departments to compile technical dossiers and meet strict submission timelines.

What you need:
Master of Pharmacy (Pharmaceutics) or a related advanced pharmaceutical degree.
7+ years' experience in Regulatory Affairs.
Deep expertise in Biologics CMC.
Proven track record with eCTD submissions to major markets (USFDA, EU, TGA) and ROW regions (LATAM, Asia, GCC, and Africa).
Ability to develop CMC regulatory strategies for essential medicines and obtain necessary agency approvals.

What You Will Get:
Remote (Based in India).
Full-time project.
Total ownership over regulatory milestones.
Worklife Balance.

If you are interested in learning more, please reach out to Linda Goba at Apsida Life Science:
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Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry.