We are looking for a highly skilled and experienced Regulatory Affairs Specialist to join our team in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a robust background in regulatory affairs, particularly in CMC.

Roles and Responsibility

- Develop and implement regulatory strategies for new products and submissions.
- Prepare and review regulatory documents, including clinical trial applications and marketing authorizations.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Conduct thorough reviews of regulatory submissions to identify areas for improvement.
- Provide training and guidance to internal stakeholders on regulatory affairs matters.
- Stay up-to-date with changing regulatory requirements and develop plans to address them.

Job Requirements

- Strong knowledge of pharmaceutical regulations, particularly CMC.
- Excellent analytical and problem-solving skills.
- Ability to work effectively in a fast-paced environment and meet deadlines.
- Strong communication and collaboration skills.
- Experience with regulatory software and systems is an asset.
- Bachelor's degree in a relevant field, such as pharmacy or life sciences.

📌 Regulatory Affairs Specialist – CMC (Bengaluru)
🏢 Naukri Healthcare Jobs
📍 Bengaluru