Senior Manager Regulatory Affairs

Syncromune•Fort Lauderdale, FL

9d•Hybrid

About The Position

The Senior Manager of Regulatory Affairs will assist in all facets of the company’s Regulatory Affairs for all U.S. and international regulatory matters, including filings and interactions with regulatory authorities. Principal Duties and Responsibilities include the following: The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management. 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. Provide strategic input on development plans and sequencing of regulatory submissions (participate in the coordination, preparation and timely submission of regulatory documents). Anticipate and mitigate regulatory risks; proactively identify opportunities for regulatory flexibility, expedited programs, and innovative pathways. Partner closely with cross-functional teams and influence program decision‑making by integrating regulatory considerations early and consistently. 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. Contribute to the evolution of regulatory strategy capabilities, regulatory internal processes, and best practices within the organization. Promote a culture of scientific rigor, regulatory strategy excellence, and proactive risk evaluation.

Requirements

Bachelor’s Degree in Life Sciences, Engineering or related field
5+ years in a regulatory capacity at a pharmaceutical company, biotech or CRO
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.

Nice To Haves

Master’s degree preferred

Responsibilities

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.
Provide strategic input on development plans and sequencing of regulatory submissions.
Anticipate and mitigate regulatory risks; proactively identify opportunities for regulatory flexibility, expedited programs, and innovative pathways.
Partner closely with cross-functional teams and influence program decision‑making by integrating regulatory considerations early and consistently.
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.
Contribute to the evolution of regulatory strategy capabilities, regulatory internal processes, and best practices within the organization.
Promote a culture of scientific rigor, regulatory strategy excellence, and proactive risk evaluation.