Specialist, US Regulatory Affairs Job in Hamilton, Ontario Canada
Purpose of Job:
The Specialist, 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.
Major Responsibilities
1.Assists in the development of strategic regulatory plans for client drug development programs.
2.Plans and prepares or assists in the preparation of all submission types (e.g. CTA, IND, NDA, BLA, Annual Reports, expedited safety reports, etc) in adherence with applicable Acts, Regulations and Guidance for submission to government agencies (focus on FDA).
3.Facilitates submission approvals through effective communication and negotiation with client, government agencies, and project team.
4.Reviews study reports, clinical protocols, Investigator's Brochures and CTD summaries, ensure they are consistent and editorially correct.
5.Responsible for supporting project workflow including prioritizing project objectives, and establishing timeframes for projects with clients with guidance from Manager. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
6.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 current clients to develop new business as opportunities arise.
7.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.
8.Assists in critical issue management strategy development.
9.Analyzes new regulations and guidelines and makes process improvement recommendations to group (SOPs, work instructions).
10.Prepares/inputs to quotes and RFPs and participates in new project / client consultations.
11.Maintains a cooperative and respectful working environment. Is available as an internal resource for peers, advising on regulatory issues and strategies.
12.Supports US business operations
- B.Sc. in a Biological, Medical, Chemical or Engineering Science. An advanced degree is preferred.
- Minimum of 3-5 years of pharmaceutical / biologics / regulatory development experience in the US regulatory environment and preferably multiple jurisdictions (EU and Canada).
- Knowledge and understanding of the development process for pharmaceutical and biological products including: CMC, non-Clinical and Clinical
- Direct experience and working knowledge of a range of US regulatory submission types.
- Demonstrated ability to interpret and utilize the Code of Federal Regulations and other FDA and ICH documents to prepare regulatory submissions.
OptumInsight is part of the family of companies that make UnitedHealth Group one of the leaders across most major segments of the US health care system.
OptumInsight is one of the largest and fastest growing health information companies. We specialize in improving the performance of the health system by providing analytics, technology and consulting services that enable better decisions and results. We integrate workflow solutions that deliver data in real-time, and create actionable insights - processing health information that relates directly to and affects one in four patients in the U.S, one in every three Medicaid dollars and one in every five emergency room visits. And we do it all with every action focused on our shared values of Integrity, Compassion, Relationships, Innovation Performance.
What can YOU do with the right information? At OptumInsight, the possibilities and the impact are limitless. No matter what your role is at OptumInsight, you'll be empowered to ask more questions, develop better solutions and help make the health care system greater than ever. It's always fresh. It's always exciting. And it's never been more important.
Diversity creates a healthier atmosphere: equal opportunity employer M/F/D/V
UnitedHealth Group is a drug-free workplace.