Associate Director, US Regulatory Affairs
(381520) UnitedHealth Group -
Hamilton, ON
Major Responsibilities
1.Effectively develops strategic regulatory plans for client drug development programs.
2.Plans and prepares all submission types (e.g. CTA, IND, NDA, Annual Reports, expedited safety reports, etc) to regulatory authorities 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. Acts as FDA liaison for client when delegated.
4.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.
5.Responsible for managing project workflow for INDs and NDAs, including prioritizing project objectives, and establishing timeframes for projects with clients with minimal supervision. 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 potential clients to develop new business.
7.Identifies project issues and develops alternate strategies for presentation to client.
8.Provides clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
9.Develops strategies for critical issue management under the supervision of directors.
10.Analyzes new regulations and guidelines and makes process improvement recommendations to group (SOPs, work instructions).
11.Prepares/inputs to quotes and RFPs and leads/participates in new project / client consultations.
12.Builds and maintains a cooperative and respectful working environment. Is available as an internal resource for peers, advising on regulatory issues and strategies.
13.Presents at industry related training seminars or workshops at industry conferences.
14.Participates in the execution of the strategic operational direction for the US business.
15.Manages a team of Managers, Associates, Specialists and/or Assistants.
Qualifications
Qualifications:
B.Sc. in Biological, Medical, Chemical or Engineering Science. An advanced degree is preferred.
Minimum of 8-10 years of pharmaceutical / biologics development experience in the US regulatory environment and preferably multiple jurisdictions (EU and Canada), including leadership and/or consulting experience.
Expert 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 wide 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 / product development strategies.
Working knowledge of venture capital and credit markets and their role in drug development
Experience in business development specifically developing and executing lead generation strategies.
Experience in people management an asset.
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.
UnitedHealth Group - 14 months ago
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