VP of Global Regulatory Affairs
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Proclinical are recruiting for a VP of Global Regulatory Affairs to join a biotech organisation. This role is on a permanent basis and is located in the US.
- Accountable for docking with HQ's regulatory affairs team to assist with international registration applications and guide a team of up to 20 personnel.
- Form a regulatory consultant team, guaranteeing consultation and resolution of challenging problems in a timely manner.
- You will be accountable for product registration methods and contribute to formulating product development methods.
- Contribute to due diligence and deliberations throughout the procedure of in/out-licensing.
- Keep up to date on regulatory guidelines and alterations, discussing the impact to the team.
- The ideal candidate will alter methods when required, examine product development risks and implement them to product development.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a biologic, medicine, pharmacy or similar discipline.
- Demonstrable regulatory experience within a biotech or pharmaceutical organisation with a background in successful investigational archiving and approvals of marketing applications from IND to BLA.
- Presentation and communication skills both verbally and in writing.
- Fluency in the English language with knowledge in Chinese would be advantageous.
- Keen to be based in the US and travel for business needs internationally.
- A background in registration methods and international product development.
- Expertise on FDA CDER or CBER divisions.
- Know-how of new drug development guidelines and FDA, EMA regulations, specifically but not limited to clinical development.
- Knowledge of the drug development procedure, GCPs and principles in clinical trial performance.
- Familiarity with regulatory proposals and IND/BLA proposals, with comprehension of their context and content.
If you are having difficulty in applying or if you have any questions, please contact Evelyn Li at +49 69 509 556 03.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.