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Executive Director (In Vitro Diagnostics and Medical Devices) Regulatory Affairs, CMC

Employer
BioMarin Pharmaceutical Inc.
Location
San Rafael, California
Start date
Dec 6, 2023

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Discipline
Quality, Quality Control, Science/R&D, CMC
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

As a Senior/Executive Director in Regulatory Affairs, CMC, focusing on diagnostics and medical devices, you will be responsible for establishing the overall regulatory strategy for contemporaneous development of devices and diagnostics for products during clinical development and life cycle management. In this role you will serve to develop a regulatory strategy that is appropriate for clinical development of the product by interfacing with key functional areas and teams across BioMarin.  This will involve a close collaboration with various product teams and functions to set up procedures for working across disciplines, and to build a framework that is consistent with the current global regulatory requirements in this rapidly changing environment.

In this leadership role, you will be responsible for a functional area within Regulatory Affairs that is strategic and that has corporate-wide impact.  This role will serve as a primary point of contact to teams and as a key contributor to governance decisions for strategic alignment and direction.  This role will support teams in early and late-stage clinical development to advance the product through critical milestones and regulatory activities that lead to registration in major territories.  You will actively build strong relationships across stakeholders, management, and with contract organizations. This role will also serve to interface with contract labs and manufactures of medical devices and diagnostics to align strategies and to serve as a key regulatory lead for stakeholder alignment.

 

KEY RESPONSIBILITIES

  • Able to effectively collaborate, negotiate, and influence strategic alignment across teams and senior level executives.
  • Able to constructively facilitate complex decision making among stakeholders and senior leaders in an area of regulatory that is complex and evolving.
  • Advise and guide the Regulatory strategy development, Health Authority interactions, and submission activities
  • Closely collaborate and participate on technical BioMarin Advisory Boards, Governance, and Steering Committees, as necessary
  • Participate in global strategic leadership meetings and forums representing Regulatory Affairs perspective related to medical devices and diagnostics.
  • Cross-functional leadership – advocate, collaborate, and build relationships across key stakeholders in Development, Research, Technical Operations, and with contract operations responsible for manufacture of medical devices and diagnostics.
  • Mentor and guide Regulatory staff and teams working across all product modalities
  • Critically review and provide input to regulatory strategy documents and regulatory submissions, including clinical trial applications (IND’s, CTA’s, etc.) and meeting briefing documents, and market applications.

Other

  • Partner closely with the Regulatory Policy group and support the BioMarin position to influence and guide external regulatory policy and changes in regulations, including taking part in the commenting process on regional regulatory guidance documents for medical devices and diagnostics used for all product modalities, including advanced therapeutics.
  • Advocate for BioMarin by building strong relationships with Health Authorities and other external stakeholders as required to facilitate sound decision-making.
  • Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
  • May have presence on external regulatory committees/trade associations

 

EDUCATION AND EXPERIENCE

  • Degree in health or life sciences, Ph.D. Preferred.
  • Significant experience with registration of Medical Devices and Diagnostics (>20 years); Knowledge of the regulatory framework for medical devices and diagnostics in all major markets, and able to apply strategic experience and solution to clinic development and marketing authorizations worldwide.


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.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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