VP of Global Regulatory Affairs

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.

Responsibilities:

• 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.

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