SVP Regulatory Affairs
Proclinical is currently recruiting for an SVP of Regulatory Affairs for a pharmaceutical company located in Hammonton, NJ. Successful candidate will be accountable for the regulatory strategy and execution of submissions for approval by the respective country authorities.
- Provide overarching regulatory strategy for both Regulatory Affairs as well as CMC
- Participate in (and lead as appropriate) all interactions with the FDA, EMA, Health Canada and other regulatory authorities, including leading label negotiations
- Identify and execute on opportunities to build a relationship of trust, scientific credibility, and partnership with relevant stakeholders within the Health Authority (FDA, EMA, etc.), leading to early engagement with the FDA to accelerate development
- Attend FDA/EMA open, public meetings relevant to the business (i.e., patient engagement, advisory committee, input on guidance, etc.)
- Ensure compliant and timely operational execution of all required regulatory updates, submissions, and reporting responsibilities
- Draft and take responsibility for key regulatory documents including IMPD, IND, IB, etc. from regulatory perspective
- Support submissions through regulatory portal
- Provide responses to regulatory agencies related to clinical study submission and drug development, from regulatory perspective
- Lead NDA and clinical strategy from regulatory perspective
- Support key health authority and supplier inspections, including PAI, GMP, etc.
Skills and Requirements:
- Masters/PhD in scientific or life sciences discipline or related required.
- 15-20 years' experience in the biopharma industry, with at least 10+ years within regulatory affairs (with at last 10 years in CMC RA).
- Proven track record of effective collaboration with the FDA/EMA, demonstrated ability to act as a credible, influential, respected spokesperson during interactions with the agency
- Demonstrated leadership experience, including managing and growing a team
- Experience with ASEAN Regulatory authorities a Plus
- Understand small molecules, biologics processes, devices, diagnostics and manufacturing aspects of product development for both oral and infusion specialty products
- Previous experience leading face to face regulatory meetings, negotiations, including end of phase meetings, Type A-C meetings, label negotiations, advisory board meetings, etc.
- Previous experience building NDA submission strategy and executing this strategy, including CMC aspects of the filing.
- Previous experience leading global Phase 3 clinical trial submissions and responses
- Experience managing and writing regulatory documents, including IMPDs, INDs, NDAs, etc.
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.
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