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Global Regulatory Lead, Senior Director

Dompé

San Mateo (CA)

On-site

USD 260,000 - 285,000

Full time

14 days ago

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Job summary

Dompé is seeking a Global Regulatory Lead, Senior Director to develop and execute regulatory strategies for product development and compliance. This role involves overseeing regulatory submissions, collaborating with cross-functional teams, and engaging with health authorities. Ideal candidates will have extensive regulatory experience in the pharmaceutical or biotech industry, with a strong grasp of U.S. and international regulations.

Benefits

Comprehensive medical benefits
Generous vacation / holiday time off
Competitive 401(K) matching

Qualifications

  • 10+ years in pharmaceutical/biotech with 8+ years in regulatory affairs.
  • Strong understanding of US and EU regulations.
  • Experience with IND, CTAs, NDAs, and BLAs.

Responsibilities

  • Develop and execute regulatory strategies for product development.
  • Oversee regulatory submissions and compliance.
  • Manage communications with regulatory health authorities.

Skills

Regulatory writing
Analytical skills
Communication
Organizational skills
Risk assessment

Education

Doctorate degree
Master’s degree
Bachelor’s degree

Tools

SharePoint
Veeva
PleaseReview
eTMF

Job description

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POSITION SUMMARY:
Dompé is seeking a Global Regulatory Lead, Senior Director that will play a critical role in developing and executing global regulatory strategies to support product development, registration, and compliance. Reporting to the Vice President of Regulatory Affairs, this position will serve as a key liaison with regulatory health authorities, oversee regulatory submissions, and provide strategic guidance to cross-functional teams. The ideal candidate will have extensive experience in regulatory affairs within the pharmaceutical or biotech industry, a strong understanding of U.S. and international regulations, and the ability to navigate complex regulatory environments to drive successful outcomes.

Primary Objectives:

  • Develop and Execute Regulatory Strategies – Provide regulatory expertise across early and late-stage clinical development, ensuring compliance with U.S. and international requirements.
  • Lead Regulatory Submissions and Compliance – Oversee the preparation, submission, and management of investigational and registration applications (eCTD) while coordinating with Regulatory Operations for e-submissions.
  • Risk Assessment and Cross-Functional Collaboration – Identify and escalate regulatory risks, ensuring seamless collaboration across teams to drive successful regulatory outcomes.

Ideal Candidate Profile:

  • Deep understanding of global regulatory frameworks (FDA, EMA, ...)
  • Expertise in IND, CTAs, NDAs, BLAs and regulatory pathways (Orphan Drug Designation,...)
  • Ability to develop and translate regulatory strategies into actionable global development plans.
  • Ability to manage multiple priorities, assess risks, and navigate complex regulatory environments with precision and flexibility.

Why This Opportunity:
Joining Dompé as a Global Regulatory Lead, Senior Director offers a unique opportunity to be part of a rapidly growing global biopharmaceutical company with a rich history of innovation. This role provides the chance to lead regulatory strategies for groundbreaking therapies, collaborate with cross-functional teams, and engage directly with health authorities to drive successful product approvals. With a dynamic and entrepreneurial culture, Dompé fosters professional growth, values strategic thinking, and empowers its employees to make a meaningful impact on global healthcare. If you thrive in a fast-paced, high-impact environment and are passionate about advancing innovative treatments, this is the perfect opportunity for you.


RESPONSIBILITIES:

  • Support Global Product Teams by contributing to and implementing regulatory strategies to optimize global product development and registration activities.
  • Manage regulatory communications/interactions with regulatory health authorities and ensure compliance with applicable regional regulations for assigned development projects in the US and ex-US countries.
  • Represent the Regulatory Affairs department on multidisciplinary product development teams.
  • Serve as primary point-of-contact for communication with regulatory health authorities on assigned programs.
  • Lead team preparations for milestone development/registration meetings with regulatory health authorities.
  • Contribute content and collaborate cross-functionally for preparation of CTA/IND/NDA/BLAs, amendments/variations, safety, and annual reports.
  • Coordinate with external vendors to maintain registration and lifecycle of assigned products globally.
  • Support investigational studies, i.e., protocol review, IND/CTA regulatory documents preparation, review, submission and maintenance, CSR review.
  • Prepare strategy for orphan drug designations, pediatric study plan and acceleration pathway applications if applicable for the assigned projects.
  • Proactively prioritize and complete multiple projects within established deadlines.
  • Maintain awareness of evolving FDA and international regulations and interpretation, competitive landscape, regulatory precedents, and work cross-functionally to implement those evolved regulations for the assigned projects.

QUALIFICATIONS:

  • Doctorate degree and 10+ years in the pharmaceutical, biotech, or related industries and 8+ years of regulatory affairs.
  • Master’s degree and 12+ years in the pharmaceutical, biotech, or related industries and 10+ years of regulatory affairs.
  • Bachelor’s degree and 14+ years in the pharmaceutical, biotech, or related industries and 12+ years of regulatory affairs.
  • Pre- and post-approval and lifecycle management experience.
  • Previous experience with SharePoint, Veeva, PleaseReview, eTMF.
  • Strong understanding of US and EU regulations.
  • Proficient regulatory writing skills
  • Strong written and verbal communication, analytical, organizational, and people skills to enable cross-functional collaboration.
  • Practical knowledge of early and late-stage clinical development programs and current US and ex-US regulatory requirements for quality, preclinical, and clinical.
  • Direct experience with investigational/registration applications in eCTD format and management of clinical trials in applicable regulatory portals (CTIS, eTMF, RIM).
  • Familiarity coordinating with Regulatory Operations group for compilation and e-submission of regulatory documents.
  • Risk assessment and appropriate escalation to the line manager and senior leadership team.


Base Salary: $260,000 - $285,000 a year

At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

We offer:

Job description:

POSITION SUMMARY:
Dompé is seeking a Global Regulatory Lead, Senior Director that will play a critical role in developing and executing global regulatory strategies to support product development, registration, and compliance. Reporting to the Vice President of Regulatory Affairs, this position will serve as a key liaison with regulatory health authorities, oversee regulatory submissions, and provide strategic guidance to cross-functional teams. The ideal candidate will have extensive experience in regulatory affairs within the pharmaceutical or biotech industry, a strong understanding of U.S. and international regulations, and the ability to navigate complex regulatory environments to drive successful outcomes.

Primary Objectives:

  • Develop and Execute Regulatory Strategies – Provide regulatory expertise across early and late-stage clinical development, ensuring compliance with U.S. and international requirements.
  • Lead Regulatory Submissions and Compliance – Oversee the preparation, submission, and management of investigational and registration applications (eCTD) while coordinating with Regulatory Operations for e-submissions.
  • Risk Assessment and Cross-Functional Collaboration – Identify and escalate regulatory risks, ensuring seamless collaboration across teams to drive successful regulatory outcomes.

Ideal Candidate Profile:

  • Deep understanding of global regulatory frameworks (FDA, EMA, ...)
  • Expertise in IND, CTAs, NDAs, BLAs and regulatory pathways (Orphan Drug Designation,...)
  • Ability to develop and translate regulatory strategies into actionable global development plans.
  • Ability to manage multiple priorities, assess risks, and navigate complex regulatory environments with precision and flexibility.

Why This Opportunity:
Joining Dompé as a Global Regulatory Lead, Senior Director offers a unique opportunity to be part of a rapidly growing global biopharmaceutical company with a rich history of innovation. This role provides the chance to lead regulatory strategies for groundbreaking therapies, collaborate with cross-functional teams, and engage directly with health authorities to drive successful product approvals. With a dynamic and entrepreneurial culture, Dompé fosters professional growth, values strategic thinking, and empowers its employees to make a meaningful impact on global healthcare. If you thrive in a fast-paced, high-impact environment and are passionate about advancing innovative treatments, this is the perfect opportunity for you.


RESPONSIBILITIES:

  • Support Global Product Teams by contributing to and implementing regulatory strategies to optimize global product development and registration activities.
  • Manage regulatory communications/interactions with regulatory health authorities and ensure compliance with applicable regional regulations for assigned development projects in the US and ex-US countries.
  • Represent the Regulatory Affairs department on multidisciplinary product development teams.
  • Serve as primary point-of-contact for communication with regulatory health authorities on assigned programs.
  • Lead team preparations for milestone development/registration meetings with regulatory health authorities.
  • Contribute content and collaborate cross-functionally for preparation of CTA/IND/NDA/BLAs, amendments/variations, safety, and annual reports.
  • Coordinate with external vendors to maintain registration and lifecycle of assigned products globally.
  • Support investigational studies, i.e., protocol review, IND/CTA regulatory documents preparation, review, submission and maintenance, CSR review.
  • Prepare strategy for orphan drug designations, pediatric study plan and acceleration pathway applications if applicable for the assigned projects.
  • Proactively prioritize and complete multiple projects within established deadlines.
  • Maintain awareness of evolving FDA and international regulations and interpretation, competitive landscape, regulatory precedents, and work cross-functionally to implement those evolved regulations for the assigned projects.

QUALIFICATIONS:

  • Doctorate degree and 10+ years in the pharmaceutical, biotech, or related industries and 8+ years of regulatory affairs.
  • Master’s degree and 12+ years in the pharmaceutical, biotech, or related industries and 10+ years of regulatory affairs.
  • Bachelor’s degree and 14+ years in the pharmaceutical, biotech, or related industries and 12+ years of regulatory affairs.
  • Pre- and post-approval and lifecycle management experience.
  • Previous experience with SharePoint, Veeva, PleaseReview, eTMF.
  • Strong understanding of US and EU regulations.
  • Proficient regulatory writing skills
  • Strong written and verbal communication, analytical, organizational, and people skills to enable cross-functional collaboration.
  • Practical knowledge of early and late-stage clinical development programs and current US and ex-US regulatory requirements for quality, preclinical, and clinical.
  • Direct experience with investigational/registration applications in eCTD format and management of clinical trials in applicable regulatory portals (CTIS, eTMF, RIM).
  • Familiarity coordinating with Regulatory Operations group for compilation and e-submission of regulatory documents.
  • Risk assessment and appropriate escalation to the line manager and senior leadership team.


Base Salary: $260,000 - $285,000 a year

At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

We offer:

● Comprehensive medical benefits: we value access to healthcare for our patients as well as our employees

● Generous vacation / holiday time off: we care about our employees and encourage a balanced lifestyle

● Competitive 401(K) matching

● A super cool team who’s excited to transform lives through innovative therapies

Seniority level
  • Seniority level
    Director
Employment type
  • Employment type
    Full-time
Job function
  • Job function
    Research
  • Industries
    Biotechnology Research and Pharmaceutical Manufacturing

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