Sr. Regulatory Affairs Contractor

As a Sr. Regulatory Affairs Contractor, you will play a critical role in ensuring that our clients therapies comply with all regulatory requirements. You will be responsible for assisting in the preparation of regulatory documents, managing regulatory timelines, and collaborating with cross-functional teams to support the development and commercialization of our products.

Responsibilities:

· Work with Regulatory Affairs leadership to develop and document processes, procedures and SOPs

· Coordinate and prepare regulatory submissions to support clinical trials, including original IND/CTA submissions, new protocols, protocol amendments, CSRs, safety reports, new investigator information, and annual reporting (eg, IND, DSUR, orphan, NDA/BLA, PADER, PBRER, etc.)

· Provide regulatory support to clinical trial teams (eg, review clinical protocols, informed consent forms, Investigator’s Brochures, and site documentation)

· Provide clinical study updates to Regulatory Affairs leadership, seeking input from regulatory colleagues as needed

· Develop and maintain regulatory knowledge of US, EU and ROW regulations to assure programs in internal processes are in compliance with applicable regulations

· Monitor regulatory intelligence and competitive environment that may impact current internal regulatory strategy.

· Coordinate and prepare responses to requests for information from health authorities

· Manage regulatory timelines and ensure timely submissions.

· Collaborate with cross-functional teams, including clinical, manufacturing, and quality assurance, to gather necessary information for regulatory submissions.

· Maintain regulatory files and documentation in accordance with company policies and procedures.

Manager Requirements:

· A BA/BS in Life Science/Health related degree or equivalent

· Minimum 3 years of Regulatory affairs or related industry experience

· Knowledge and understanding of global regulatory regulations and guidelines

· Hematology and/or oncology preferred

· CDX experience preferred

· Ability to work in a cross-functional team environment and a flexible team-oriented perspective

· Strong attention to detail and the ability to handle multiple tasks

· Excellent organizational, computer and documentation skills.

· Strong interpersonal skills and the ability to deal effectively with various team members including medical, scientific and manufacturing staff