The Role
The Senior Manager of Regulatory Affairs supports U.S. and international regulatory activities for pharmaceutical, biotech, combination, and medical device products. Responsibilities include preparing and reviewing IND, BLA, and other regulatory submissions; developing submission strategies; managing regulatory risks; coordinating cross-functional filings; responding to agencies; maintaining documentation; and improving regulatory processes and SOPs. The role requires oncology experience, strong technical writing and editing skills, regulatory expertise, and the ability to manage multiple priorities.
Summary Generated by Built In
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.
Education:
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range: $160,000-180,000
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.
#Remote
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.
- 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
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range: $160,000-180,000
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.
#Remote
Skills Required
- Bachelor's degree in Life Sciences, Engineering, or a related field
- 5+ years of experience in a regulatory capacity at a pharmaceutical company, biotech company, or CRO
- 2+ years supporting oncology products
- Strong understanding of regulatory requirements, interpretations, and information sources
- Experience authoring regulatory documents, including IND sections, IND amendments, agency responses, and expedited program applications
- Proficiency with Microsoft Office Suite or similar software
- Proficiency with applicable database and compliance software
- Ability to manage multiple competing priorities
- Excellent organizational and project management skills
- Excellent communication, collaboration, verbal, writing, editing, and proofreading skills
- Excellent analytical and problem-solving skills
- Knowledge of the competitive oncology drug marketplace and research and development pipelines
- Master's degree
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The Company
What We Do
Syncromune is a privately held, clinical-stage biopharmaceutical company dedicated to developing SYNC-T, a potentially first-in-class, in situ personalized combination immunotherapy platform. The company focuses on developing transformative therapies for metastatic solid tumor cancers, aiming to synchronize the immune system to recognize and attack cancer throughout the body. Their goal is to provide potential curative benefits for patients with incurable metastatic solid tumors.
