Manager - Regulatory Affairs (Biosimilars)
NOVUMGEN is seeking an experienced Regulatory Affairs Manager to lead documentation and compliance strategies for biosimilars and complex formulations. The role involves overseeing regulatory dossiers, providing technical expertise in bioprocesses, and ensuring alignment with USFDA and EMA guidelines. Candidates should possess 8-12 years of experience in the biologics domain and hold an M.Sc. or M. Tech degree. This position requires strong leadership to guide cross-functional teams and mentor junior staff.
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Experience
8-12 years
Function
Research
Work mode
Onsite, India
Company
Tier 2
What you will work on
NOVUMGEN is seeking an experienced Regulatory Affairs Manager to lead documentation and compliance strategies for biosimilars and complex formulations. The role involves overseeing regulatory dossiers, providing technical expertise in bioprocesses, and ensuring alignment with USFDA and EMA guidelines. Candidates should possess 8-12 years of experience in the biologics domain and hold an M.Sc. or M. Tech degree. This position requires strong leadership to guide cross-functional teams and mentor junior staff.
TAL's take
Solid mid-tier healthtech role with clear scope in regulatory affairs, though the company is relatively unfamiliar.
The JD clearly defines the scope, technical expertise, and responsibilities for the regulatory affairs manager role.
Must haves
- 8–12 years of relevant regulatory affairs experience
- Expertise in biosimilars and complex formulations
- Knowledge of global regulatory frameworks like USFDA and EMA
- M.Sc. or M. Tech in Biotechnology or related life sciences
Tools and skills
About the company
Unfamiliar company, default mid-tier assigned.