FierceBiotech and FiercePharma Jobs
Manager, Regulatory Affairs - Shore Personnel Consulting, LLC
Aug 06
Location: Bradley Beach, NJCategories: Pharmaceutical
Position Description
MANAGER, REGULATORY AFFAIRS
Direct position as full time employee of our client, a pharmaceutical firm located in Philadelphia, PA
The Manager, Regulatory Affairs will report to the Executive Director, Regulatory Affairs and will be responsible for certain projects in development and play an integral role in the regulatory affairs activities for the company. Other responsibilities will include:
•Act as regulatory representative on product development teams; participate in the review of Investigator Brochures, non-clinical reports, clinical protocols, CMC and IND/NDA submissions
•Assemble, review, and file original INDs and manage IND maintenance activities (amendments, including annual reports and safety reports); coordinate NDA submissions activities
•Manage FDA liaison activities for assigned development projects
•Liaison with regulatory colleagues in Europe
•Manage CRO communications and coordinate outsourced activities
•Provide regulatory support for development programs, including clinical supplies, packaging, manufacturing, pre-approval inspections, etc.
•Assist in the development of global standards and regulatory SOPs
Must have a minimum of a BS degree in a scientific discipline; an advanced degree is very desirable. Should have 3-5 years of minimum experience within regulatory affairs and experience with US regulatory submissions. Knowledge of regulations and guidelines is required; and RAC certification is preferred. Specific qualifications and other skills and abilities desired include:
•An understanding of the current Regulatory environment and demonstrated ability to perform in it.
•Practical knowledge of US and ICH regulations and guidance and the ability to assure compliance
•Demonstrate ability in IND and NDA preparation and support.
•Demonstrated ability to effectively perform in a team environment
•Demonstrated ability to adhere to and support regulatory strategies
•Demonstrated history of successful FDA interactions
•Positive attitude, assertive, ability to work with minimal supervision
•Ability to adapt to changing priorities in an intense area of drug development
•Microsoft Office
•Time management
•Comfortable working and communicating independently
This position requires excellent partnering, strong interpersonal skills and leadership abilities. Compensation package includes a competitive salary plus stock options, depending on relevant experience, and an excellent benefits package.
