Director / Senior Director, Regulatory Affairs

Location
San Carlos, CA
Posted
Jun 12, 2018
Required Education
Bachelors Degree
Position Type
Full time

Alkahest is looking for a Director / Senior Director, Regulatory Affairs  who can apply his or her knowledge of global regulations governing pharmaceutical drug development to all aspects of Alkahest’s manufacturing, preclinical and clinical drug development programs, policies, and procedures.  This person is highly-collaborative, low maintenance, creative and self-starting and thrives in a dynamic & fast-paced environment.  He or she is an experienced, hands-on professional ready to embrace the challenge of establishing a department from the ground up.

Playing a key role in the organization this individual will be providing regulatory support for each of Alkahest’s clinical and pre-clinical project teams. 

Responsibilities:

  • Develop regulatory development and approval strategies in collaboration with senior management and by analysis of guidances and assessment of drugs developed for similar indications
  • Manage/lead regulatory activities associated with Alkahest’s drug development programs
  • Manage the planning, preparation, submission and maintenance of INDs, IMPDs, NDAs, BLAs, MAAs, Orphan Drug Applications and other regulatory submissions as appropriate
  • Continually monitor newly published FDA guidelines and international guidance documents with respect to Alkahest’s current and future development programs & provide training on applicable requirements for scientific & clinical staff as required
  • Function as the primary liaison with FDA and other regulatory agencies

Requirements:

  • Requires advanced degree in a science-related discipline or relevant experience demonstrating scientific competence at a similar level (e.g., Ph.D, PharmD, MD, MS, RN, etc.)
  • A minimum of 8 years of pharmaceutical industry experience, at least 5 of which should include regulatory duties
  • Thorough knowledge of the drug-development process, with a focus on IND/CTA and NDA/BLA/MAA processes
  • Knowledgeable of GxP environment cGMP, GLP, GCP environments and regulations experience required
  • Knowledgeable of US standards 21CFR210, 21CFR211, 21CFR11 and ICH Quality Guidelines
  • Experience in a functional domain such as discovery, clinical operations, CMC, or another area of drug development highly desired
  • Experience with the Office of Blood Research and Review (OBRR) and/or the Division of Neurology Products (DNP) highly desired
  • Travel may be required 10 - 20% of the time
  • Must possess excellent written and verbal communication skills