Zevra Therapeutics
Vice President, Head of Regulatory Affairs
Zevra Therapeutics, Boston, Massachusetts, us, 02298
Vice 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 in all of our clinical and regulatory development strategies.
About the Role
The VP, Head of Regulatory Affairs is the company’s 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. The role blends strategic leadership with hands‑on execution, suited to a lean organization.
What You’ll Do
Portfolio & Product Strategy
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 up‑to‑date and involved in the regulatory rare disease environment.
Lead informed go/no‑go decisions cross‑functionally.
Submissions & Approvals
Own and direct major submissions and label negotiations.
Ensure inspection readiness and submission quality.
Prepare and lead Health Authority meetings and Advisory Committee meetings.
Hands‑on execution of regulatory activities in cross‑functional collaboration.
Post‑Approval & Lifecycle Management (Commercial Products)
Set and execute LCM roadmap.
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.
Development Programs (Clinical & CMC Integration)
Anticipate and steer expedited pathways and special designations.
Shape endpoints/COAs for rare diseases.
Drive CMC readiness for pivotal/registration.
Integrate patient voice and EAP/CUP considerations.
Leadership & Organization
Build and develop a high‑performing RA organization.
Foster talent development and mentorship to cultivate future regulatory leaders.
Establish operating rhythms and decision forums to ensure cross‑functional communication, timely decision‑making and tracking of progress.
Set and manage budgets and vendor strategy.
Governance, Quality & Systems
Partner with QA on GxP compliance and inspection readiness.
Own RA systems and documentation flows.
Drive intelligence and policy monitoring.
\ Enterprise Impact
Advise Executive Team and Board on regulatory risk/mitigation.
Ability to effectively communicate with internal customers, third‑party partners, and regulatory authorities.
Represent the company externally at stakeholder meetings, conferences, and consortia.
Qualifications
Required
Advanced scientific degree or equivalent experience.
15+ years in Regulatory Affairs with significant rare‑disease expertise.
Strong expertise in US/EU Regulatory Affairs in all drug stages from development to commercialization and experience with roll‑out to global markets.
Demonstrated leadership of major submissions and successful HA engagements.
Hands‑on experience integrating CMC, clinical, nonclinical evidence.
Strong team leadership in resource‑constrained settings.
Proficiency with eCTD, RA publishing, and EDMS tools.
Preferred
Experience with EAP/CUP, RWE strategies, COA/endpoint development.
Public speaking at AdComs or major scientific/regulatory forums.
Equal Employment Opportunity Statement 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,, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Notice to External Recruiters Zevra does not accept unsolicited resumes from agencies or search firms. Recruiters are requested not to contact employees or hiring managers. All candidate submissions must be coordinated through our Human Resources team and require a prior written agreement. Any resumes sent without such an agreement will not create any implied obligation.
Referrals increase your chances of interviewing at Zevra Therapeutics by 2x
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Cambridge, MA $266,400.00-$325,600.00 1 month ago
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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 development strategies.
About the Role
The VP, Head of Regulatory Affairs is the company’s 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. The role blends strategic leadership with hands‑on execution, suited to a lean organization.
What You’ll Do
Portfolio & Product Strategy
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 up‑to‑date and involved in the regulatory rare disease environment.
Lead informed go/no‑go decisions cross‑functionally.
Submissions & Approvals
Own and direct major submissions and label negotiations.
Ensure inspection readiness and submission quality.
Prepare and lead Health Authority meetings and Advisory Committee meetings.
Hands‑on execution of regulatory activities in cross‑functional collaboration.
Post‑Approval & Lifecycle Management (Commercial Products)
Set and execute LCM roadmap.
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.
Development Programs (Clinical & CMC Integration)
Anticipate and steer expedited pathways and special designations.
Shape endpoints/COAs for rare diseases.
Drive CMC readiness for pivotal/registration.
Integrate patient voice and EAP/CUP considerations.
Leadership & Organization
Build and develop a high‑performing RA organization.
Foster talent development and mentorship to cultivate future regulatory leaders.
Establish operating rhythms and decision forums to ensure cross‑functional communication, timely decision‑making and tracking of progress.
Set and manage budgets and vendor strategy.
Governance, Quality & Systems
Partner with QA on GxP compliance and inspection readiness.
Own RA systems and documentation flows.
Drive intelligence and policy monitoring.
\ Enterprise Impact
Advise Executive Team and Board on regulatory risk/mitigation.
Ability to effectively communicate with internal customers, third‑party partners, and regulatory authorities.
Represent the company externally at stakeholder meetings, conferences, and consortia.
Qualifications
Required
Advanced scientific degree or equivalent experience.
15+ years in Regulatory Affairs with significant rare‑disease expertise.
Strong expertise in US/EU Regulatory Affairs in all drug stages from development to commercialization and experience with roll‑out to global markets.
Demonstrated leadership of major submissions and successful HA engagements.
Hands‑on experience integrating CMC, clinical, nonclinical evidence.
Strong team leadership in resource‑constrained settings.
Proficiency with eCTD, RA publishing, and EDMS tools.
Preferred
Experience with EAP/CUP, RWE strategies, COA/endpoint development.
Public speaking at AdComs or major scientific/regulatory forums.
Equal Employment Opportunity Statement 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,, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Notice to External Recruiters Zevra does not accept unsolicited resumes from agencies or search firms. Recruiters are requested not to contact employees or hiring managers. All candidate submissions must be coordinated through our Human Resources team and require a prior written agreement. Any resumes sent without such an agreement will not create any implied obligation.
Referrals increase your chances of interviewing at Zevra Therapeutics by 2x
Sign in to set job alerts for “Head of Regulatory Affairs” roles.
Cambridge, MA $266,400.00-$325,600.00 1 month ago
#J-18808-Ljbffr