Sr. Director Strategic Global LabelingLocation San Rafael, California Workstyle Remote Only Apply
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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 or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients’ lives.
The Sr. Director of Regulatory Global Labeling (REG-GL) is a strategic role leading the development of labeling for products worldwide. Responsibilities may include developing labeling content and strategies for Target Product Labeling, Company Core Data Sheets, Prescribing Information, Patient Labeling, and Instructions for Use. The incumbent will be responsible for regulatory compliance, competitive, and up-to-date labeling. The Sr Director of REG-GL will lead cross functional Product Labeling Teams as a Global Labeling Lead or supervise staff in this role, directing team members on labeling content, requirements, and strategies for good labeling outcomes and success. This role would also be responsible for strategic regulatory labeling health authority interactions and negotiations for labeling projects assigned. End to end labeling process oversight is expected for products assigned to ensure proper handoff and compliance. Oversees and mentors labeling professionals to achieve regulatory objectives.
This position will be responsible for:
- Lead or direct the creation of high quality labeling and supporting documents for new or changes to the CCDS or local labeling. Review of summary documents such as clinical overviews to ensure the labeling message is consistent with the overall representation of a marketing application.
- Manage the compliance of local labeling against approved CCDS concepts.
- Lead Product Labeling Teams or serve as Senior leader to Labeling Leads to ensure labeling is compliant with the local regulations, supports business goals, and processes are followed.
- Present and defend proposed labeling changes in global product information documents, including labeling documents in key markets to Senior Management as required for review and approval.
- Provide regulatory strategic guidance and oversight of global labeling activities for commercial products and development products in various therapeutic areas as assigned. May include presenting and influencing Regulatory Leadership and/or Executive Labeling Committee on an ad-hoc/issue-driven basis for assigned projects/products.
- An active member on Regulatory, Development, Safety, Commercial teams supporting the requirements for labeling claims in-line with corporate goals. This may include interactions with Regulatory International and regional Partners.
- Responsible for the development of labeling negotiations strategic plan for the assigned labeling projects and conduct health-authority reviews and label negotiations (in writing, phone or in person as needed). Lead US and EU labeling negotiations for the assigned products. Guide/ support REG International for all labeling related HA negotiations and participate in labeling negotiation meetings or teleconferences with HAs, as needed.
- Provide strategic input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices, and align with global strategic labeling plan.
- Create and lead the development of labeling processes and support system development to enhance labeling processes as needed.
- Guide launch teams or provide Senior leadership to Labeling Leads on launch strategy for new commercial products or labeling implementation requirements for labeling changes. May interact with Commercial, Supply Chain and Technical Operations staff.
A minimum of 12 years required of industry experience and extensive experience (at least 6-8 years) in labeling; alternatively extensive experience in related areas of the Pharmaceutical Industry or Health Authorities.
- Experienced leader with management and direct reports.
- Experience negotiating with internal and external stakeholders on complex regulatory issues of importance to BioMarin.
- Seasoned regulatory professional with experience in submissions for products in development and commercial products.
- Thorough understanding of regulatory labeling requirements and strategic labeling planning.
- Outstanding interpersonal and communication (written and verbal) skills.
- Excellent writer or labeling content with attention to detail.
- Prior experience leading cross functional teams.
- History of solving regulatory labeling related problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
- Fluency in English as business language, additional languages advantageous.
- Expertise in global labeling and managing project teams including international teams (not in the same time-zone).
- Biologics and rare disease experience is desirable.
- US labeling expertise required, with additional International and Core Labeling experience desired.
Minimum requirements Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
This position will have supervisory role with direct report(s).
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.