Lead regulatory projects ensuring compliance and representing Conagra Brands in food safety matters. Collaborate across departments to harness regulatory opportunities for business growth.
About the role
- Senior Manager of Regulatory Affairs supporting regulatory activities for oncology clinical studies. Collaborating with cross-functional teams to ensure compliance and successful submissions to regulatory agencies.
Responsibilities
- Provide ownership of molecule and study-level regulatory activities, including global clinical trial applications (CTAs) and IND submissions
- Review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the studies as necessary
- Contribute and drive the regulatory content and strategy for BLA, NDA or marketing authorization submissions
- Provide regulatory guidance internally on study-team decisions
- Update study team of regulatory activities in the context of study team management meetings
- Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfilled conditions/commitments
- Collaborate with cross-functional study team for planning of regulatory documents, including health authority meetings and responses to health authority queries
- Support processes by which regulatory submissions are reviewed, finalized, and signed-off
- Manage the record of regulatory/ethics submissions and approvals across all studies
- Manage document archive processes
- Support global regulatory submissions and strategic planning as applicable
- All other duties as assigned
Requirements
- BA/BS degree in the biological or health related sciences required
- Masters, PhD or PharmD preferred
- Minimum of 3+ years of experience in regulatory affairs
- Minimum of 7+ years of pharmaceutical, biotechnology, or life sciences industry experience
- Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry-standard practices
- Possess strong written, oral communications
- Demonstrate proven interpersonal skills and experience working cross-functionally throughout the organization
- Detail-oriented, ability to work proactively, organize, prioritize, and delegate assigned projects
- Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations preferred as well as ex-US health authority interactions, meetings etc.
- Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
- Knowledge of Chinese is desirable
Benefits
- Actual compensation may include bonus, stock, benefits and/or other applicable variable compensation
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