Sr. Director, Corporate Counsel - Regulatory

Company: BioMarin Pharmaceutical Inc.
Location: San Rafael
Posted on: May 12, 2022

Job Description:

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. This Senior Director, Corporate Counsel will serve as the functional lead for BioMarin's Global Regulatory organization and will have direct client responsibility supporting a broad range of R&D related activity. Counsel will work closely with cross functional partners and other attorneys in the company's Legal Department on matters relating to regulatory requirements for investigational and approved products, regulatory submissions, pharmacovigilance and product labeling. This is an exciting opportunity to join a talented group of attorneys in support of developing and commercializing innovative therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. The successful candidate for this position will have significant specialized experience with FDA regulatory requirements in the biopharmaceutical industry and strong business acumen. Responsibilities

• Provide legal guidance to the Regulatory organization and product teams regarding interactions with regulatory agencies.
• Review, strategize and advise on key regulatory filings and briefing documents.
• Partner with cross functional pre-launch team to develop target product profiles and target labeling; anticipate and advise on label and approval challenges.
• Stay abreast of key activities at regulatory agencies and provide updates about the potential impact on product approvals and marketed products.
• Work with Pharmacovigilance to ensure compliance with safety reporting, risk management and other post marketing safety commitments.Experience and Skills Required
  • 7+ years of experience, including at a major law firm, advising on regulatory requirements in the biopharmaceutical industry.
  • Deep knowledge and experience with regulatory submissions, agency regulations and drug safety management.
  • Excellent organization and time-management skills. Must be able to manage multiple projects and aggressive timelines in a diligent manner, prioritize and work under pressure.
  • Must be detail-oriented, self-motivated, a quick learner, and have a strong work ethic.
  • Exceptional written and communication skills.
  • Strong team orientation. Must be able to collaborate effectively in a dynamic, fast-paced, cross functional environment.
  • Ability to think critically and strategically and to creatively problem solve.
  • Ability to work onsite at San Rafael, CA headquarters at least three days a week strongly preferred.
  • Experience in-house or FDA preferred.Education J.D. required from a nationally recognized law school. Current California Bar membership or eligibility for in house counsel registration required. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Keywords: BioMarin Pharmaceutical Inc., San Rafael , Sr. Director, Corporate Counsel - Regulatory, Executive , San Rafael, California