Manager, Regulatory Affairs CMC

Company Name:
Job Description
This position represents Regulatory CMC for assigned biologic products that either marketed or in the development pipeline. This role will actively partner with regulatory therapeutic area counterparts to establish alignment with the product regulatory strategies and to communicate regulatory CMC requirements to team members both internally and externally. This position also will be responsible for the development of CMC related documents for IND/IMPD/CTA,MAA and lifecycle management submissions, ensuring that they meet current regulatory standards, are high quality, consistent, complete, and approvable on the first review cycle. Provide effective RA CMC representation on a variety of development and post-approval product teams. Participate in outside meetings, forums, etc to ensure the latest thinking is applied to CMC strategies.
Position Requirements
A minimum of 5-7 years of increasing documented success in biopharmaceutical field, with at least 3 of those years in regulatory affairs biotechnology CMC. Electronic CTD submissions experience a plus.
BS/MS in a scientific discipline.
Additional Notes
1. Self-motivated/pro-active and strategic thinker
2. Proven track record in biotechnology CMC regulatory field
3. Effective in a highly matrixed organization and able to manage external business partners
4. Comfort interacting with senior managers
5. Excellent oral and written communication skills
6. Strong interpersonal /group skills
7. Strong work ethic and entrepreneurial spirit
8. Ability to interpret, understand and effectively communicate within MedImmune all relevant FDA, ICH, RoW regulatory CMC requirements
9. Operate independently
10. Proven management skills
Title: Manager, Regulatory Affairs CMC
Location: MD, Gaithersburg - Corporate Headquarters
Req ID: 8213
Position Category: Regulatory Affairs

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