Director, Regulatory Affairs

Location
Emeryville, CA, United States
Posted
Aug 22, 2020
Ref
owSrbfwK
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
At Santen, we're innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field-through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.We are in search of top talent to help us meet our aggressive and important goals.

This position 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 position also leads the U.S. regulatory team based in the US Headquarters in Emeryville, CA.

Responsibilities:
  • Plan and prepare documentation for designated INDs, NDAs, PLAs and related filings to regulatory agencies.
  • Lead the Filing team through NDA planning and submission, including pre-NDA meetings and managing post-submission information requests.
  • Communicate and interact within department, division (Inc.), external organizations and corporation on regulatory related items.
  • Review and evaluate reports, briefing packages for agencies' meetings, and comprehensive submissions for regulatory authorities.
  • Represent Santen Inc. in communications with regulatory authorities and present strategies for product approval with the appropriate regulatory authorities.
  • Provide leadership within department to ensure that regulatory requirements are understood and followed by Santen personnel.
  • 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.
  • Advise the executive management of Santen Inc. regarding product registration strategy.
  • Coordinate the preparation of amendments, supplements and annual reports for regulatory submissions.
  • Make decisions that impact the department, division (Inc.), and corporation.
  • Provide regulatory leadership for project teams, functional areas, executive management at Inc., and during meetings with agencies.
  • Ensure successful pre-approval inspections resulting in marketing clearance.
  • Participate as a member on Corporate Regulatory Affairs Committee and/or other corporate committees.
  • Develop and administer performance requirements for Regulatory staff.
  • Provide mentorship to the regulatory team.
  • Participate in development of Santen products internationally through Regulatory Affairs and Project Management.
  • Represent Santen in domestic and international professional regulatory organizations.
  • Provide leadership in selecting methods and techniques for obtaining solutions.
Requirements:
  • Bachelors in a scientific field required; Advanced Degree preferred.
  • 10+ years' experience in regulatory affairs with specific focus on FDA and Health Canada
  • 15+ years' experience in the pharmaceutical and/or ophthalmic industry
  • Minimum 5+ years successful management experience
  • Effective negotiation and decision making skills
  • Direct experience negotiating with the FDA
  • Experience in pre-approval inspections
  • 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