VP of Global Regulatory Affairs job in New York, USA

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Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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First Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Senior/Director & VP

Location: United States

This vacancy has now expired. Please see similar roles below...

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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