Regulatory Associate- Biosimilar combination product
Regulatory Associate- Biosimilar combination product
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Job Description
We are seeking a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations). This role will be responsible for developing and executing global regulatory strategies for combination product devices ensuring compliance with evolving regulatory requirements from agencies such as the FDA EMA MHRA and other global health authorities.
Qualifications :
5 years of regulatory affairs experience in biosimilars biologics or combination product development.
Additional Information :
- Provide regulatory guidance on device design human factors risk management and manufacturing considerations.
- Lead and coordinate regulatory submissions for biosimilar combination products including IND BLA and EU MDR filings.
- Ensure accurate regulatory documentation for design control risk assessment usability studies and post-market surveillance.
- Work closely with R&D Quality Clinical and Manufacturing teams to align regulatory strategies with product development.
- Support design verification and validation activities including human factors engineering (HFE) and risk management.
- Provide regulatory support for product lifecycle management including manufacturing changes labeling updates and device modifications.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
