Senior Associate, Regulatory Affairs

Proclinical, in support of our client, are seeking an individual to fill the role of Senior Associate, Regulatory Affairs, based in New Jersey. The incumbent will independently author, compile, review and submit high-quality regulatory submissions to the FDA.

Responsibilities

• Interact effectively with functional business units to coordinate/facilitate procurement of documentation required for submissions, ensuring that departmental timelines are met.
• Review technical documents for accuracy and acceptability.
• Author, compile and review ANDAs, NDAs, Amendments, Supplements and Annual Reports.
• Review and sign off on change control documentation.
• Assess changes and their impact to the business based on an advanced understanding of regulatory guidelines and applicable federal laws.
• Assist in formulating strategies in support of submission goals.
• Communicate regulatory requirements and strategies as they affect regulatory submissions to internal and external partners.
• Represent regulatory affairs in project team meetings and provide regulatory guidance and perspective to team members.

Skills And Qualifications

• BA or higher in a life sciences related field and 5+ years in the pharmaceutical industry with 3-4 of those years in regulatory affairs.
• Excellent written, verbal, and interpersonal communication skills.
• In-depth knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output.
• Ability to make appropriate decisions on regulatory activities and work outputs.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kyle Weber at (+1) 646-367-2618 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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