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

• 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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