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Senior Manager of Regulatory Affairs, Oncology

3 weeks ago

Fort Lauderdale, Florida, United States Syncromune, Inc. Full time

The 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:

  • Work with the EVP of Regulatory Devices and Combination Products 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, NDA's, 510 (k)'s, IDE's, and PMA's.
  • Participate in the design control process to establish quality plans and Design History Files.
  • 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.

Qualification Requirements:

Education:

  • Bachelor's Degree in Life Sciences, Engineering or related field
  • Master's degree preferred

Experience:

  • 2+ years in a regulatory capacity at a pharmaceutical company or CRO
  • Experience with Regulatory Devices and Combination Products a plus
  • High degree of understanding of regulatory requirements, how they operate, how to obtain updated information and where to obtain interpretations of them
  • 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 immuno-oncology marketplace and in research and development pipelines.

Working Conditions:

  • 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

Syncromune is an Equal Opportunity Employer.

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: $135,000-$150,000

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company's benefit plans.

Remote