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Senior Regulatory Affairs Director

Company: Proclinical Group
Location: Rockville
Posted on: September 15, 2020

Job Description:

You are here: Home > Senior Regulatory Affairs Director

Location: United States

Rockville, USA Reference: RA.NW.28942

This vacancy has now expired

Proclinical is currently recruiting for a Senior Regulatory Affairs Director with a leading biotechnology company located in Rockville, MD. Successful candidate will prepare for meetings, teleconferences, and other communications with FDA and other regulatory agencies, educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process.

Job Responsibilities:

Lead the development of global regulatory strategy, ensuring that programs meet quality and safety standards required by patients, health care providers, and regulatory agencies.

Coordinate and balance priorities of various stakeholders (corporate, scientific, clinical) in the context of regulatory requirements, through active participation in Product Development Teams.

Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices.

Provide critical review of all documentation supporting regulatory applications, including organization of regulatory file rooms and document signatures.

Lead the preparation and submission of regulatory submissions to FDA and other regulatory agencies.

Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.

Monitor applicable current and new regulatory requirements.

Review and update regulatory processes and documentation practices to ensure company is in compliance and audit ready.

Interact with company partners and consultants on regulatory matters.

Contribute to the regulatory perspective on government proposals and external due diligence activities.

Skills and Requirements:

Advanced Degree (M.S. or Ph.D. preferred) in a Biological Science.

7+ years' regulatory affairs biologics industry experience required, vaccine experience preferred.

Direct interaction experience with FDA required.

Thorough knowledge and practical application of domestic and international regulations including cGMPs, GLP, GCP and ICH.

Experience with submissions via eCTD (electronic gateway).

Excellent writing skills are required.

Excellent leadership, interpersonal, written and oral communication skills.

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 Nicholas Walker at (+1) 646-367-2908 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.

Proclinical Staffing is an equal opportunity employer.

Proclinical is currently recruiting for a Regulatory Associate of Labelling with a global pharmaceutical company located in Collegeville, PA.

An amazing vacancy has arisen for a Senior Associate in Regulatory Affairs, this is a home-based role at a talented biopharmaceutical company.

Proclinical is currently recruiting for a US Regulatory Lead with a biotechnology company located in Chicago, IL.

A large biopharmaceutical company are looking for a talented Regulatory Affairs Senior Manager focused on the APAC (Asia Pacific) region join their team in Maidenhead.

Proclinical is currently recruiting for a Regulatory Associate with a pharmaceutical company located in Rockville, MD.

Proclinical is currently recruiting for a Regulatory Affairs Associate with a biopharmaceutical company located in Rockville, MD.

Proclinical is currently recruiting for a US Regulatory Lead with a biotechnology company located in Cambridge, MA.

Proclinical is currently recruiting for a Regulatory Affairs Associate with a pharmaceutical company located in San Mateo, CA.

Proclinical is currently recruiting for a US Regulatory Lead with a biotechnology company located in Durham, NC.

Proclinical is currently recruiting for a REMOTE Regulatory Operations Associate with a pharmaceutical company located in Princeton, NJ.

By submitting this form, you consent to allow Proclinical to store and process the personal information above and send communications to you to provide the information and/or services you have requested. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, check out our Privacy Policy .

Keywords: Proclinical Group, Rockville , Senior Regulatory Affairs Director, Other , Rockville, Maryland

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