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Manager, US Regulatory Affairs - Telecommute
| Hours | Full-time, Part-time |
|---|---|
| Location | Ann Arbor, MI Ann Arbor, Michigan |
About this job
We're changing the way health care works for the better. That means consulting with our members, partnering with our physicians, and delivering drugs in the most efficient and effective way. Join us and start doing your life's best work.(sm)
The Manager, Regulatory Affairs has responsibility for managing strategic regulatory operations and providing expert advice on the guidelines and regulations to clients within the US Regulatory environments.
Primary Responsibilities:
- Develops a strategic regulatory plans for client drug development programs under supervision of Director
- Plans and prepares all submission types (e.g. CTA, IND, NDA, Annual Reports, expedited safety reports, etc) to regulatory authorities with minimal supervision in adherence with applicable Acts, Regulations and Guidance for submission to government agencies (focus on FDA)
- Facilitates submission approvals through effective communication and negotiation with client, government agencies, and project team
- Reviews and/or authors study reports, clinical protocols, Investigator's Brochures and CTD summaries, ensuring that all documents are accurate and consistent with applicable regulations and guidance Reviews draft submissions for regulatory content and editorial viewpoint
Responsible for managing project workflow for INDs and NDAs including prioritizing project objectives, and establishing timeframes for projects with clients with guidance from Director - Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met
Participates in formal interactions (face-to-face meetings, teleconferences, etc.) with clients and government agencies - Builds positive working relationships with clients and government agency contacts. Interacts with potential clients to develop new business
Identifies project issues and develops alternate strategies for presentation to client. Provides clients with advice in response to their queries, based on regulatory experience and area of expertise - Assists in critical issue management strategy development
- Analyzes new regulations and guidelines and makes process improvement recommendations to group (SOPs, work instructions)
- Prepares/inputs to quotes and RFPs and participates in new project / client consultations
- Maintains a cooperative and respectful working environment. Is available as an internal resource for peers, advising on regulatory issues and strategies
Supports US business operations - Manages a team of Associates, Specialists and/or Assistants
Requirements
Required Qualifications:
- B.Sc. in a Biological, Medical, Pharmaceutical, Chemical or Engineering Science. An advanced degree is preferred
- Minimum of 5 years of pharmaceutical / biologics US regulatory environment and preferably multiple jurisdictions (EU and Canada)
- 5 years of direct experience and working knowledge of a range of US regulatory submission types
- Knowledge and understanding of the development process for pharmaceutical and biological products including: CMC, non-Clinical and Clinical
- Demonstrated ability to interpret and utilize the Code of Federal Regulations and other FDA and ICH documents to prepare regulatory / product development strategies
Preferred Qualifications:
- Experience in people management and/or project management
Careers with Optum. Here's the idea. We built an entire organization around one giant objective; make health care work better for everyone. So when it comes to how we use the world?s large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do your life's best work.(sm)
Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.
Job Keywords: Manager, US Regulatory, Regulatory Affairs, regulatory operations, drug development, CTA, IND, NDA, safety reports, FDA, Food and Drug Administration
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