Job Postings

The Vice President, Regulatory Affairs is responsible for providing strategic leadership and direction for all of Adamas’ global regulatory projects, in addition to, overseeing the execution of activities to support the company’s registration goals.  The Vice President, Regulatory Affairs will design, develop and execute long term strategies into short term goals for regulatory/clinical and CMC strategies, in alignment with department, company and commercial goals.

This position will be expected to lead and collaborate with multiple internal stakeholders to ensure that all programs are implemented in accordance to with project team strategies and in compliance with global regulatory agencies, and that overall business strategies are translated to guarantee optimal time to market.

This position reports to the Senior Vice President, Product Development and is based in Emeryville, CA.

Specific Responsibilities:

  • Develops robust regulatory strategies and policies
  • Leads global regulatory intelligence initiatives
  • Ensures effective planning, preparation and submission of IND’s, IMPD, NOC, and marketing license applications in the U.S. and globally
  • Liaises closely with the CMC, clinical and project teams and partners with project team leaders to ensure all regulatory requirements are met, and all information needed for registration and on going product availability is produced
  • Serves as the lead for the regulatory sub-teams and represent regulatory affairs on the project teams
  • Builds, manages and effectively leads a team of regulatory global professionals and consultants
  • Provides feedback, coaching and professional development opportunities for direct reports
  • Establishes project related goals and monitors timelines
  • Manages the regulatory budget, timelines, including staffing and hiring needs
  • Establishes and manages relationships with external regulatory authorities and maintains correspondence/communication and other records of interactions
  • Coordinates and leads meetings with regulatory agencies
  • Serves as the global regulatory expert within the company
  • Informs Adamas’ senior management of changes in regulatory directives, guidance, and regulations
  • Advises staff members and colleagues on regulatory matters and provides guidance in conducting studies that comply with FDA and global requirements
  • Clearly communicates critical regulatory information to team members in all phases of the development cycle
  • Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations

Qualifications:

  • PhD, M.D. or J.D. degree highly preferred
  • 15+ years regulatory affairs experience in a pharmaceutical or biotech company, including senior management experience
  • Proven ability to develop robust regulatory/clinical and CMC strategies
  • Experience in negotiating with the FDA and other worldwide health agencies: anticipating concerns, proactively addressing issues and challenges, and effectively finding solutions
  • In depth experience with the U.S. and European regulatory requirements, demonstrated by submission and approval of multiple successful NDA/MAA’s
  • Experience and understanding of the major Asia Pacific and Latin America regulatory requirements, a plus
  • Flexible, adaptable, diplomatic, and able to effectively deal with ambiguity
  • Demonstrated ability to communicate effectively both verbally and in writing across all levels and can effectively present information to both technical and non-technical audiences
  • Experience developing and delivering effective regulatory and management presentations
  • Demonstrated ability to creatively solve complex problems and deal with issues and challenges with effective solutions
  • Excellent leadership skills in managing and motivating a team of regulatory professionals
  • Ability to build trust with others through demonstration of credible technical skills and follow-through on commitments
  • Experience developing and managing budgets
  • Results oriented leader who conveys a sense of urgency and drives for closure
  • Successful experience in fast-paced entrepreneurial environment
  • Fit with Adamas culture and values

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Committed to developing new medicines to improve the daily lives of people affected by chronic neurologic disorders.

About Adamas
  • Headquarters:
    Emeryville, Calif.
  • Employees: ~70
  • Initial Public Offering: April 2014
  • Nasdaq: ADMS