Mgr – Regulatory Affairs Pharma – Healthcanada
| Company | Fresenius Medical Care |
|---|---|
| Location | Dallas, TX, USA, Raleigh, NC, USA, Vaughan, ON, Canada, Chicago, IL, USA, Waltham, MA, USA, Atlanta, GA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s Degree required
- 6 – 8 years’ related experience
- Knowledge, comprehension and application of scientific principles are required
- Must be knowledgeable of and have experience in applying FDA drug regulations
- Strong oral and written communication skills
- Computer proficient
Responsibilities
- Manage the company’s pharmaceutical products and the associated RA staff
- Facilitates regulatory strategy development and other compliant alternatives to product team
- Facilitates clinical strategy development in providing regulatory guidance and intelligence on acceptable approval strategies
- Assists in the short and long term schedule planning for the Product Team
- Authoring, reviewing and coordinating quality submissions to regulatory agencies for viable product strategies and product submission
- Assists in interactions with the FDA and other regulatory agencies
- Builds professional relationships with the FDA project managers and other key personnel
- Provides strong leadership and support within the department
- Provides coaching and counseling and advice to direct report employees
- Provides feedback to employees on a consistent basis
- Works with employees to develop clear and concise development plans to ensure the advancement of future talent
- Responsible for the annual assessment for all direct report employees
- Ensures FDA commitments are met in a timely manner
- Provides regulatory review, feedback and /or approval for relevant documents, including advertising and promotional materials
- Arranges and prepares for meetings, teleconferences, and other communications with the FDA
- Liaises with Regulatory Operations for timely submission of electronic and paper submissions
- Provides opportunities for on-going job-related education to the pharmaceuticals RA staff
- Provides regulatory input and feedback for subcontractor selection and management
- Provide technical guidance
- Assist with various projects as assigned
- Other duties as assigned
Preferred Qualifications
- Advanced Degree desirable
- 3+ years’ supervisory or project/program management experience preferred
- Experience in regulatory publishing templates highly desirable