Sr. Director, Corporate Counsel - Regulatory
Company: BioMarin Pharmaceutical Inc.
Location: San Rafael
Posted on: May 12, 2022
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
- 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
- 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
- Ability to think critically and strategically and to creatively
- 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
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