Remote: Regulatory Project Manager (229918)

Life Sciences & Technology | Regulatory Affairs
Share

Job Description:

Our client is looking for a Regulatory Project Manager for an 8 month contract. The ideal candidate has Clinical Development and Clinical study experience. This role will be the regulatory side of the trial and coordinating with CRO’s on the regulatory aspect of the trial for ensuring the compliance aspect of the data and documentation. This person will be the lead and driver of the clinical sites for management of health authority inspections, clinical protocol development, IND, CTD for upcoming submissions. This individual must have a strong background with licensing applications and approvals. This person will sit as the regulatory strategy lead for the sites and product development teams.

 

Required Experience: 

  • Must have experience with Regulatory, Vaccine/Biologics and Clinical Trial experience.
  • Proven success as the regulatory submission lead (overseeing, coordinating, and preparing submissions with cross-functional team; executing strategy to meet timelines; writing cover letters/forms; following eCTD structure and requirements) to receive IND/CTA/NDA/BLA/NDS or supplement approval
  • Leading rapid response team to respond to regulatory authority queries
  • Leading health authority meeting preparations (supporting rehearsals with MW and team, e.g. including meeting package and slides)
  • Represent RA in internal and external cross-functional meetings, e.g. with project team, CRO, vendors
  • Previous vaccine experience or if not, at least biologics experience (US definitely but CA/UK/EU good as well)
  • Previous experience with FDA advisory committee (preferable)

 

Remote: Regulatory Project Manager (229918)

#LI-Remote

#LI-CB1

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

Apply Now