Senior Director, Global Regulatory Affairs

Location
Emeryville, CA, United States
Posted
Oct 03, 2020
Ref
o2d1cfwc
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Role

The Senior Director of Global Regulatory Affairs is responsible for the planning, integrating, and developing Santen Inc.'s regulatory strategy and managing regulatory activities, leading to rapid approval of Santen products and/or appropriate maintenance of marketed products. This is a hands-on leadership role and will provide strategic and operational leadership for the direction, planning, execution and conduct of regulatory objectives, projects and submissions. This position will lead a U.S. regulatory team of six; a two Sr. Regulatory Specialists, two Sr. Regulatory Affairs Specialists and a Regulatory Affairs Manager, and a Director, Regulatory Affairs.

Responsibilities

The Sr. Director will define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Specific responsibilities include:
  • Provide strategy for US and Canadian registration of Santen Products and occasionally the integration of US strategy into a global regulatory strategy on global projects.
  • Provides strategic and tactical advice to the team to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
  • Is a leader within Santen and external to Santen, contributing to cross-functional initiatives and influencing the field.
  • Provides leadership and development for six (6) direct reports.
  • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
  • Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Sr. Director will lead all submission types.
  • Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings.
  • Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Santen affiliates in compliance with local regulations and to maintain compliance for products.
  • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
  • Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
  • Responsible for demonstrating Santen leadership behaviors.

Qualifications

The successful candidate must be a skilled relationship developer, employ an entrepreneurial spirit, and passionately embody the Santen mission.
  • Minimum 10+ years successful management experience.
  • 12+ years of experience in regulatory affairs with specific focus on FDA and Health Canada.
  • 15+ years of experience in the pharmaceutical or biotech industry (ophthalmic experience preferred).
  • Experience developing staff/people.
  • Effective negotiation and decision making skills.
  • Direct experience negotiating with the FDA.
  • Experience in pre-approval inspections.
  • Experience in registration of sterile products.
  • Experience leading project teams.
  • Experience managing regulatory professionals.
  • Thorough knowledge of GMPs, GLPs, GCPs, ICH guidelines, and US regulatory guidelines.
  • Working knowledge of EU and Japanese regulations.
  • Proficient at intermediate level with Microsoft Office suite of software.
  • Excellent written, verbal and presentation skills.
  • Demonstrated ability to collaborate cross-functionally.
  • Proven track record of effective planning and organizational skills.
  • Ability to originate and complete projects with little to no oversight.
  • Ability to interact successfully with multiple diverse cultures.
Education
  • Bachelor's in a scientific field required; Advanced Degree preferred.

Goals and Objectives

Within the first 12-24 months, the Sr. Director will have been expected to:
  • Develop and file NDAs.
  • Build relationship with the industry experts.
  • Participate in speaking engagements, panel discussions, publications, etc.
  • Be looked upon within Santen as a can-do, hands-on leader, who has integrated well into Santen entrepreneurial culture.