Regulatory Affairs Manager
Proclinical is currently recruiting for a Regulatory Affairs Manager with a global pharmaceutical company located in Warren, NJ. Successful candidate will be responsible for providing regulatory leadership, strategic direction and support in the development, evaluation, and marketing of medical device and drug products.
- Leverage relevant regulatory knowledge and experience to help develop creative regulatory strategies, product labelling and product claims.
- Advise and collaborate on regulatory requirements to support new product development, product modifications, product registration and regulatory submissions.
- Plan, conduct and manage the coordination and compilation of pre and post-market regulatory submissions, and responses to regulatory agencies questions and other correspondence as needed, in accordance with regulatory agency regulations and guidelines.
- Understand the US regulatory landscape and provide assessments of the impact of new and changing regulations.
- Provide executive summaries and/or status updates on product/project activities to key internal/external stakeholders.
- Identify and clearly communicate gaps or risks that may impact implementation and acts where necessary to minimize delays and anticipated difficulties.
- Create label text drafts and review labels in accordance with local requirements.
- Manage updates to internal regulatory databases
Skills and Requirements:
- 5+ years of direct US regulatory experience in a medical device environment.
- Direct US regulatory experience with OTC drug products is a plus.
- BS or equivalent technical discipline.
- Other professional certifications (i.e. RAC) a plus.
- Ability to analyze complex oral and written governmental/regulatory positions and provide practical analysis and advice.
- Strong technical acumen, including interpretation and documentation.
- Strong knowledge of Medical Device Quality Systems (i.e. FDA 21 CFR 820, ISO 13485).
- Strong communication skills.
- Ability to work in a team environment.
- Proactive and self-motivated; a sense of urgency.
- Experience with FDA databases.
- Proficient in Microsoft Office Applications (Outlook, Word, Excel), document management systems and publishing tools.
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 Sarah Beshara at (+1) 267-477-3355 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.