W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9jbhnyzxnvdxjjaw5nig5ldy9qcgcvbmv3lwjhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

VP Regulatory Affairs

VP Regulatory Affairs

  • Location

    San Francisco CA, United States

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    $200,000+

  • Contact:

    Callum Sparkes

  • Job ref:

    43980

  • Published:

    9 months ago

  • Expiry date:

    2019-08-19

  • Consultant:

    #

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