Senior Regulatory Affairs Director
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.
- 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.
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.