Director, Regulatory Affairs Job at Meet Life Sciences, South San Francisco, CA

VlEwNmYzV20ySG1VMEF1RWlTd1R6SWlXRHc9PQ==
  • Meet Life Sciences
  • South San Francisco, CA

Job Description

Director, Regulatory Affairs

*Hybrid Role - 2-3x per week onsite in South San Francisco*

Meet has partnered with an exciting biotech that is looking for a Director of Regulatory Affairs to join their team. Our client is focused in developing treatments for rare hematology/immunology indications and has several clinical-stage programs. Our team placed the hiring manager (SVP Regulatory Affairs) and a Director of RA in this function and both have had wonderful things to say about the organization.

Key Responsibilities

  • Lead the development and implementation of strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
  • Provide regulatory advice and information to cross-functional teams and to other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals.
  • Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities

Key Qualifications

  • 8+ years of pharmaceutical Regulatory Affairs experience
  • Experience supporting/leading major regulatory submissions required (IND/CTA, NDA/BLA/MAA)
  • Oncology/hematology experience required
  • Small biotech experience strongly preferred

Please reach out to Ryan Moran if you're interested in learning more:

✉: ryan.moran@peoplewithchemistry.com

Job Tags

Similar Jobs

Advantage Solutions

Part Time Brand Ambassador Inside Whole Foods Market Job at Advantage Solutions

 ...a dynamic and personable Part Time Brand Ambassador to join our team in representing leading consumer goods companies within Whole Foods Market. This role is perfect for someone who thrives in a social environment and is passionate about providing an engaging and informative... 

GERNON MARCHAND ENTERPRISES LLC

Independent Contractor Courier (Backup) Job at GERNON MARCHAND ENTERPRISES LLC

 ...Job Description Job Description Independent Contractor Courier (Backup)Location: Duncansville, PA 16635 Were seeking a motivated, trustworthy, and responsible driver to serve as a backup courier for our Duncansville route. This role is perfect for someone... 

Pottstown Nursing & Rehab

Licensed Practical Nurse - LPN Job at Pottstown Nursing & Rehab

 ...Waive your PTO and/or benefits and earn 10-15% more based on location Paid training on the job with an experienced mentor Tuition Reimbursement, Voluntary insurances, including pet insurance, term and whole life, short-term disability, hospital indemnity, personal... 

University Health/University Medicine Associates - Universit...

Orthopaedic Surgery - Physician Job at University Health/University Medicine Associates - Universit...

 ...compensation, a supportive work environment, access to advanced facilities, and benefits including relocation assistance and visa sponsorship. Orthopedic Surgeon / Surgery Job Opportunity in San Antonio University Health is seeking a Board-Certified or Board-Eligible... 

Department of Public Health

INVESTIGATOR Job at Department of Public Health

 ...salary rate of $6,974.00 under Pay Scales Section 5. The Investigator conducts extensive and complex investigations; initiates enforcement...  ...Special Requirements The position(s) require(s) a Background Investigation be cleared prior to being hired. The position...