The RA Manger will prepare and facilitates meetings / teleconferences with regulatory agencies and advise team members on the applicability of new regulations and guidelines. Will be responsible for the maintenance of various clinical and nonclinical regulatory documents, including INDs/BLAs/NDAs and ensure that the elements, quality, accuracy and format of regulatory submissions comply with applicable laws, regulations and corporate standards.

 Responsibilities include:

• Serves as the regulatory representative on various project subteams and addresses a broad range of problems of moderate scope
• Manage project plans and timelines for multiple projects
• Perform literature searches, prepare special reports and assemble documentation to support project teams
• Applies knowledge of FDA regulations and ICH guidelines to provide regulatory guidance and contribute to strategic planning on project teams
• Develop and maintain departmental processes, policies, SOPs and associated documents
• Lead or participate in department initiatives, task forces, and training

The qualified candidate will have:

• Minimum of 5 years regulatory/clinical experience is required
• 4-year degree required, advanced degree preferred
• Knowledge of drug development regulations

Industry: Pharmaceuticals, Biologics, Clinical research Regulatory Affairs

Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

Job Code: BHJOB1778_175

The Wellington Group ( http://www.twgrecruiters.com )

The RA Specialist will be involved with both pre and post-marketing duties in support of the Regulatory Director and QA Manager. Will consider individual from pharmaceutical, medical devices, veterinarian and biologics companies.

Responsibilities include:

• Draft correspondence for transmission to FDA, USDA and other government regulatory agencies
• Assist in authoring various post-marketing FDA and USDA annual product reports, establishment registrations, state licenses, and other related regulatory reports
• Assist with preparation and compilation of regulatory submissions including IND, BLA, MAA, and supplements
• Maintain Regulatory Affairs files and regulatory correspondence log

The qualified candidate will have:

• Minimum of 1 year regulatory experience is required
• 4-year degree required, life scientific degree preferred
• 1-3 years in a GMP environment
• Aseptic or sterile based manufacturing knowledge is ideal

Industry: Biologics, Biotechnology, Pharmaceuticals

Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

Job Code: BHJOB1778_207

The Wellington Group ( http://www.twgrecruiters.com )