Regulatory Affairs / RA Manager ( CMC )
Sterling Life Sciences - Seattle, WA

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1) Contribute to the development of CMC regulatory strategy appropriate to the stage of product development
2) Implement strategy to advance projects through development to product registration
3) Understand CMC regulatory requirement including FDA and ICH guidelines and relevant government regulations as apply to the registration, development and approval of investigational products as well as post approval changes to marketed products
4) Drive content of CMC documentation to regulatory agencies (IND / CTA, NDA / MAA), setting the standards for CMC regulatory submissions to ensure adequacy, completeness and regulatory accuracy
5) Co-ordinate the preparation of CMC submissions through editing and approval of final draft documents including review for quality
6) Co-ordinate preparation of information and related activities for CMC meetings with health authorities
7) Interact with domestic and foreign regulatory agencies on CMC issues
8) Serve as the regulatory representative at project meetings and interact with personnel from corporate partners in order to achieve common goals
9) Negotiate and interact with and supervise the activities of contract manufacturing organizations in the preparation of regulatory submissions, as necessary
10) Manage regulatory CMC activity within time and budget for approved project plans
11) Communicate project status and issue to manager in a timely manner
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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (No students or fresh graduates please)
3) Recent experience in the biopharmaceutical industry is strongly preferred
4) Preference will be given to people have recent experience in regulatory affairs