VP, Regulatory Affairs

Job description

This position will manage the day-to-day regulatory activities of assigned projects for compounds under development. These activities include acting as the regulatory representative on core teams, developing and planning regulatory submission strategy, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities. The VP, Regulatory Affairs, will work closely with members of the R&D team, interact with regulatory agencies and ensure the timely preparation of scientifically valid submissions.

Responsibilities:

  • Responsible to help set global and program specific regulatory strategy, and execution thereof
  • Manage regulatory activities for assigned projects, including representation on the core/project development teams
  • Participate in meetings and interact with members of core/project teams to convey regulatory requirements and develop a strategy to meet corporate goals
  • Serve as the primary interface for FDA, EMA and other regulatory agencies on assigned projects
  • Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.
  • Work with cross-functional teams to define contributions to submissions
  • Lead the regulatory submission teams for projects assigned within defined time schedules and following established standards
  • Represent the Regulatory Affairs Department in interdepartmental meetings
  • Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines
  • Contribute to the development and maintenance of Regulatory Affairs working practices and procedures

Qualifications:

  • Bachelors or advanced degree in scientific/life-sciences or related field with at least 12 years of pharmaceutical industry experience and 8+ years of direct regulatory affairs experience
  • Experience in multiple phases of development in various therapeutic areas
  • Neurology or Ophthalmology experience required
  • Thorough knowledge of the drug development process, with focus on IND and NDA processes Experience with small molecule products and working with international regulatory agencies is highly desired
  • Demonstrated ability to interface with relevant regulatory authorities
  • Demonstrated experience preparing new IND and/or NDA submissions and supportive material (electronic submission experience is a plus)
  • Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy
  • Results driven and team-oriented with the ability to influence outcomes
  • Excellent organizational, written and verbal communications, project and time management skills needed to drive multiple ongoing projects simultaneously
  • Must be able to innovate, analyze and solve problems and have exceptional attention to detail

Additional Information:

Please include a cover letter that highlights your qualifications and matches our requirements and send resumes to resumes@annexonbio.com.