Executive Director Regulatory Affairs & Quality
Proclinical is currently recruiting for an Executive Director of Regular Affairs and Quality with a global biopharmaceutical company located in Philadelphia, PA. Successful candidate will be responsible for directing day to day activities that include participating in submissions both domestic and international, interactions with regulatory agencies, working collaboratively to create drug and device development plans that are integrated with Regulatory strategy.
- Contribute to formulation and execution of regulatory affairs and quality strategy pertaining to all relevant Company goals and objectives.
- Direct domestic and global regulatory projects, determine submission requirements, plan submission process, and work with cross functional team to coordinate and approve regulatory documentation for inclusion in US and global regulatory submissions.
- When appropriate, perform regulatory review of manufacturing, quality and research, documents, provide facilitative commentary and feedback, and assume responsibility for regulatory approval for relevant documents.
- Consult with and manage external regulatory affairs and quality consultants.
- Monitor trends and changes in regulations and advise internal stakeholders on the potential impact to current and future strategy and tactics.
- Work with internal stakeholders to ensure that all relevant Company activities are in conformance and compliance with quality and regulatory law and guidance.
- Represent Regulatory Affairs and Quality on project teams to communicate the necessary requirements and facilitate the fulfillment of these requirements.
- Administrative responsibility for Quality and Regulatory staff including training, performance appraisals, staffing and salary recommendations.
Skills and Requirements:
- BS degree, preferably in a scientific or health related field. An advanced degree in a scientific area of study is strongly preferred.
- Regulatory Affairs Certification (RAC) strongly preferred.
- Domestic and international regulatory submissions and interactions experience. This experience should span the spectrum of regulatory affairs activities inclusive of chemistry and manufacturing controls (CMC), research and development, and drug/device combo.
- Experience with both pharmaceuticals and medical devices is preferred.
- Domestic and international experience strongly preferred.
- Leadership and facilitation in a cross functional team environment.
- Willingness to accept and meet challenges.
- Strategic thinking and tactical implementation.
- Solid PC skills including Microsoft Office Suite.
- The ability to handle multiple tasks independently.
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.