IW
Individual Workspace
Senior Regulatory Associate
Bengaluru · India · Hybrid
Job description
The Senior Regulatory Associate will support preparation and submission of regulatory dossiers for health authorities in the United States and Europe. The role works within the regulatory affairs team to ensure compliance with regional requirements.
Responsibilities
- Prepare and compile regulatory submission dossiers for US and European health authorities.
- Coordinate with cross‑functional teams to gather required data and documentation.
- Maintain up‑to‑date knowledge of regulatory guidelines and submission timelines.
- Respond to agency queries and provide supporting information during review.
Requirements
- Bachelor’s degree in life sciences, pharmacy, or related field.
- Minimum 5 years of experience preparing regulatory submissions for US and EU markets.
- Demonstrated ability to interpret regulatory guidelines and apply them to dossier content.
- Strong written communication skills for preparing submission documents and responses.
Preferred skills
IND filing, NDA preparation, EU CTA submission, regulatory intelligence, project management, cross‑functional collaboration
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