Sr Manager Regulatory Affairs, Oncology
- Support the Senior Director of Regulatory Affairs to ensure adherence to appropriate regulations and standards.
- Assists with determining regulatory requirements and prepare regulatory submission for all new/modified combination products, drugs, and medical devices. These submissions can include but not be limited to IND’s, BLA’s, meeting packages and expediated programs. .
- Participate in the coordination, preparation and timely submission of regulatory documents.
- Ensure project teams prepare high quality international and domestic filings/registrations and responses to agency requests within established timelines.
- Review submission packages for compliance with global regulations.
- Write and edit technical documents.
- Review and create standard operating procedures (SOPs).
- Ensure regulatory documentation is maintained appropriately.
- Interact with regulatory agencies as required.
- None
Education:
- Bachelor’s Degree in Life Sciences, Engineering or related field
- Master’s degree preferred
- 5+ years in a regulatory capacity at a pharmaceutical company, biotech or CRO with 2+ years supporting oncology products.
- High degree of understanding of regulatory requirements, how they operate, how to obtain updated information and where to obtain interpretations of them
- Experience in authoring part of regulatory documents such as M1, M2 of an IND, IND amendments, response to regulatory agency’s IR, expediated program applications.
- Ability to inform and educate managers and department heads on regulations and policies that require compliance
- Ability to translate regulatory requirements into practical, workable plans
- Proficient with Microsoft Office Suite or similar software
- Proficient with applicable database and compliance software
- Must be able to juggle multiple and competing priorities
- Excellent organizational and project management skills.
- Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed.
- Excellent attention to detail.
- Must have outstanding communication and collaboration skills within cross-functional teams and external organizations.
- Ability to work in a fast-paced virtual environment.
- Excellent verbal and writing skills.
- Excellent analytical and problem-solving skills
- Excellent editing and proof-reading skills.
- Possess a self-directing, self-starting work ethic.
- Excellent knowledge of the competitive environment for drugs in the oncology marketplace and in research and development pipelines.
- The work environment shall be split between a virtual office environment and the Company headquarters in Fort Lauderdale, FL.
- Domestic travel up to 10% of time
- Ability to lift up to 25 pounds
- Regularly required to stand, sit, talk, hear, and use hands
- Prolonged periods of sitting and standing
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