Vice President, Head of Regulatory Affairs
1 week ago
Vice President, Head of Regulatory Affairs
We are a rare disease therapeutics company leading with science to make lifechanging therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory development strategies.
With a keen understanding that drug development often requires creative solutions, we have the insight and expertise to forge new pathways to success that others have missed. By following the data without bias, our transparent narratives and commonsense perspective have successfully overcome complex development challenges to make muchneeded therapies available to patients.
Nimble and dauntless, we push boundaries beyond what is thought to be possible and advance new therapies that have the potential to bring meaningful improvement to patients lives.
The VP, Head of Regulatory Affairs is the companys senior regulatory executive and a member of the leadership team. This leader owns the global regulatory strategy and execution across the portfolio consisting of commercial products and development assets. The VP of RA demonstrates exceptional leadership skills and a passion for fostering professional growth within their team as well as improving the internal processes in the department. Define and continuously optimize global regulatory strategies (US/EU) for marketed and development programs.
Collaborate with internal customers, SMEs and other partners/stakeholders to ensure regulatory risk is factored in business plans and decisions.
Keep uptodate, and be involved in the regulatory rare disease environment.
Ensure inspection readiness and submission quality.
Handson execution of regulatory activities in crossfunctional collaboration.
PostApproval & Lifecycle Management (Commercial Products)
Accountable for regulatory compliance activities to maintain Marketing Authorizations worldwide (periodic reporting, fee payment, safety reporting, promotional material, etc.).
Support GxP compliance impacts on regulatory documentation, labeling and commitments.
Drive CMC readiness for pivotal/registration.
Integrate patient voice and EAP/CUP considerations.
Foster talent development and mentorship to cultivate future regulatory leaders.
Set and manage budgets and vendor strategy.
Governance, Quality & Systems
Partner with QA on GxP compliance and inspection readiness.
Drive intelligence and policy monitoring.
Advise Executive Team and Board on regulatory risk/mitigation.
Ability to effectively communicate with internal customers, thirdparty partners, and regulatory authorities.
Advanced scientific degree or equivalent experience.
~15+ years in Regulatory Affairs with significant raredisease expertise.
~ Strong expertise in US/EU Regulatory Affairs in all drug stages from development to commercialization and experience with rollout to global markets.
~ Experience with EAP/CUP, RWE strategies, COA/endpoint development.
~ Public speaking at AdComs or major scientific/regulatory forums.
Zevra is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
-
Vice President, Head of Regulatory Affairs
2 weeks ago
Boston, MA, United States Zevra Therapeutics, Inc. Full timeVice President, Head of Regulatory Affairs We are a rare disease therapeutics company leading with science to make life-changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory development strategies. With a keen...
-
Vice President, Head of Regulatory Affairs
2 weeks ago
Boston, MA, United States Zevra Therapeutics, Inc. Full timeVice President, Head of Regulatory Affairs About Zevra Therapeutics, Inc. We are a rare disease therapeutics company leading with science to make life‑changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory...
-
Vice President, Head of Regulatory Affairs
1 week ago
Boston, MA, United States Zevra Therapeutics, Inc. Full timeVice President, Head of Regulatory Affairs About Zevra Therapeutics, Inc. We are a rare disease therapeutics company leading with science to make life‑changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory...
-
Vice President, Head of Regulatory Affairs
2 weeks ago
Boston, MA, United States Zevra Therapeutics, Inc. Full timeVice President, Head of Regulatory Affairs Do you have the following skills, experience and drive to succeed in this role Find out below. About Zevra Therapeutics, Inc. We are a rare disease therapeutics company leading with science to make life‐changing therapeutics available to patients with significant unmet needs. We involve key thought leaders,...
-
Vice President, Head of Regulatory Affairs
3 weeks ago
Boston, United States Zevra Therapeutics Full timeVice President, Head of Regulatory Affairs 1 day ago Be among the first 25 applicants About Zevra Therapeutics, Inc. We are a rare disease therapeutics company leading with science to make life‑changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups...
-
Vice President, Head of Regulatory Affairs
3 weeks ago
Boston, MA, United States Zevra Therapeutics, Inc. Full timeVice President, Head of Regulatory Affairs About Zevra Therapeutics, Inc. We are a rare disease therapeutics company leading with science to make lifechanging therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory...
-
Vice President, Head of Regulatory Affairs
6 days ago
Boston, MA, United States Zevra Therapeutics, Inc. Full timeVice President, Head of Regulatory Affairs About Zevra Therapeutics, Inc. We are a rare disease therapeutics company leading with science to make life-changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory...
-
Boston, MA, United States Zevra Therapeutics, Inc. Full timeA rare disease therapeutics company is seeking a Vice President, Head of Regulatory Affairs to own global regulatory strategy across its portfolio. The role involves collaboration with stakeholders, managing submissions, and building a high-performing team to navigate regulatory affairs in a lean organization. Candidates should have 15+ years of experience...
-
Boston, MA, United States Zevra Therapeutics, Inc. Full timeA rare disease therapeutics company is seeking a Vice President, Head of Regulatory Affairs to own global regulatory strategy across its portfolio. The role involves collaboration with stakeholders, managing submissions, and building a high-performing team to navigate regulatory affairs in a lean organization. Candidates should have 15+ years of experience...
-
Boston, MA, United States Zevra Therapeutics, Inc. Full timeA rare disease therapeutics company is seeking a Vice President, Head of Regulatory Affairs to own global regulatory strategy across its portfolio. Make sure to apply with all the requested information, as laid out in the job overview below. The role involves collaboration with stakeholders, managing submissions, and building a high-performing team to...
