Senior Manager, Regulatory Affairs Specialist
5 days ago
We are seeking a highly skilled Senior Manager, Regulatory Affairs III to join our team at ATR International.
Key Responsibilities:
- Prepare high-quality CMC sections for INDs/IMPDs, marketing authorization applications, post-approval variations, renewals, and responses to agency questions.
- Collaborate with cross-functional teams to develop global CMC regulatory strategies for international markets.
- Liaise with Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, and third-party local agents to develop filing plans and deliver submissions.
- Coordinate regulatory assessments for post-approval CMC changes and develop filing strategies for assigned markets.
Requirements:
- Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience.
- Experience in preparing CMC components of MAA or post-approval variation submissions for small molecule and/or biologics products.
- Biologics experience or drug-device combination product experience is an advantage.
- Proven ability to coordinate the preparation of CMC regulatory documents in collaboration with other functions.
- Strategic thinking skills with a proven track record for developing global CMC regulatory strategies in multiple markets simultaneously.
- In-depth knowledge of ICH and regional CMC regulatory requirements.
- Excellent written and verbal communication skills.
Preferred Qualifications:
- Experience with Veeva Vault, including RIM.
- Global regulatory expertise.
About this Role:
This is a great opportunity to gain experience in a CMC RA team, develop knowledge of Regulatory Affairs, and support the team in regulatory-related activities.
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