Director, Regulatory Affairs Global Lead
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.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
- Leads a team of global regulatory professionals for development and marketed products. Accountable for ensuring that corporate goals are met. Manages the content of global regulatory dossiers. Key internal leader and driver of regulatory policy and strategy for assigned products.
- Leads preparation of global regulatory product strategies for assigned products. Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.
- May participate in or lead initiatives. May have direct report and contributes to the performance management for other RA team members. Influences the development of regulations and guidance. Advises management of the effect of current or proposed laws, regulations, guidelines and standards, etc.
- Advises internal personnel on regulatory strategies. Follows company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department.
- Ensures alignment of global regulatory strategies with Sr. Management. Proactively informs management of issues, risks and mitigations. Provides assessment of impact on global programs. Provides informed regulatory opinion based on experience and expertise.
- Works with GRT to develop, communicate goals that are in alignment with the business goals. Establishes and communicates to regulatory team and cross-functionally the immediate to long-range plans to carry out program objectives.
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
- Preferred Education: Relevant advanced degree is preferred.
- 7+ years regulatory experience (including development of product strategy in regions globally). Proven 3-5 years in a leadership role with strong management skills.
- Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams.
- Strong clinical foundation preferred with business acumen.
- Strong communication skills.
- Experience contributing to management of products.
- Experience interfacing with health authorities.
- Experience developing and implementing successful global regulatory strategies.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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Job posted: 2020-04-27