Previous Job
Dir/AD Regulatory Affairs
Ref No.: 18-00578
Location: South San Francisco, California
Position Type:Contract
Experience Level: 10 Years
Director/Associate Director Regulatory Affairs
South San Francisco, CA
Contract (6 months)
  • Lead multiple regulatory activities (nonclinical, clinical and in vitro diagnostic) to assure timelines and milestones are met to support the business needs of the company
  • Lead the implementation of innovative global registration strategies and ensure cross functional alignment
  • Develop regulatory strategies to reduce regulatory risks associated with clinical, nonclinical and CMC sections of an NDA/MAA; work with respective teams to implement them
  • Serve as primary contact for global regulatory authorities
  • Plan, execute and lead successful regulatory agency meetings and interactions per regulatory strategy
  • Define content for and direct the organization and preparation of high quality and effective regulatory submissions, including future marketing applications (eg NDA and MAA)
  • Review and approve clinical study protocols, informed consent forms, statistical analysis plans, clinical study reports, investigator brochures, responses to regulatory agencies and all regulatory submissions
  • Provide regulatory expertise for development of product labels and core data sheet
  • Serve as regulatory liaison with government partners, business partners and CROs
  • Provides leadership on project teams in all areas of regulatory affairs
  • Prepare and deliver effective presentations for external and internal audiences as needed
  • Maintain knowledge and monitor changes in pertinent laws, regulations and guidance's. Interpret external developments and inform/educate stakeholders
  • A minimum of a Bachelor's degree in a scientific discipline required. A Master's or Doctorate degree preferred
  • At least 10 years' experience in the Pharmaceutical or Biotechnology industry
  • RAC certification also preferred but not required
  • Experienced in Regulatory Affairs with a proven track record in implementing strategies
  • Experienced in submitting INDs, NDAs, and MAAs and in managing international regulatory filings
  • Comprehensive understanding and applied knowledge of global regulatory requirements for the development and approval of investigational products
  • Well-developed critical reasoning skills and in risk management assessments
  • Proven ability to collaborate across multiple functions and build effective relationships
  • Demonstrated ability to work in a dynamic environment with a high degree of flexibility
  • Excellent team interaction skills along with demonstrated ability to work in a cross functional team and influence the decisions of a team.
  • Demonstrated excellence in independent management of complex projects
  • Strong written and verbal communication skills and presentation effectiveness
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive
  • Available to travel domestically and internationally, if needed
Please call Lindsey Summers with questions at 303-694-5482
Feel free to connect to Lindsey on LinkedIn:
And join discussions on Changing FDA Regulatory landscape in the United States:

Ascent Life Sciences specializes in Medical Device, Pharmaceutical, Biotech, and clinical validation search for contract staffing, contract-to-hire, direct hire search and small project consulting services for FDA-regulated industries