Biogen
Head of Regulatory Affairs and Pharmacovigilance, WCH
Biogen, San Francisco, California, United States, 94199
Overview
Summary Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. We are seeking a highly experienced and dynamic Head (VP) of Regulatory Affairs and Pharmacovigilance to lead regulatory and safety strategies at the Biogen West Coast Hub (WCH). This leader will be accountable for shaping and executing comprehensive regulatory strategies to enable timely, successful interactions with global health authorities. You will lead and develop high-performing teams across Regulatory Affairs, Pharmacovigilance, and Medical Writing, fostering a culture of collaboration, scientific rigor, and operational excellence. The VP should bring both a track record of successful regulatory approvals, a passion for challenging conventional regulatory paradigms, and demonstrated leadership capability in building, mentoring, and scaling global development organizations. Responsibilities
Strategic Leadership & People Management As a key member of the West Coast Hub leadership team, provide forward-looking strategic direction and thought partnership, collaborating with cross-functional leaders to shape organizational priorities and drive long-term success. Champion a professional, inclusive, and high-performance culture where employees are valued, empowered, and heard. Manage multi-functional teams spanning Regulatory Affairs, Pharmacovigilance, and Medical Writing, ensuring that functional strategies are tightly aligned with program, portfolio, and corporate objectives. Recruit, develop, and mentor top talent, fostering a culture of accountability, innovation, and continuous growth while building strong succession pipelines for critical leadership roles. Provide a clear vision and operational discipline to ensure teams are not only executing effectively but also anticipating future needs, leveraging external market insights and internal capabilities to position the organization for sustained impact. Regulatory Strategy & Execution Develop and execute global regulatory strategies for Biogen West Coast Hub programs/molecules. Represent Regulatory Affairs at executive level governance and other decision making forums. Oversee preparation and submission of all global regulatory filings, including INDs, CTAs, Investigator’s Brochures (IBs), DSURs, NDAs, and related submissions. Mentor and lead global regulatory affairs professionals who serve as the primary point of contact for global regulatory authorities (e.g., FDA, EMA, NMPA, PMDA), leading all communications and meetings. Strategize, lead, and/or supervise the development and submission of documents/plans (e.g., Orphan, Breakthrough, Fast Track, Accelerated Approval, Diversity, Pediatric Plans) to support development goals. Drug Safety, Pharmacovigilance & Medical Writing Oversight Provide strategic direction and oversight of drug safety and pharmacovigilance operations, ensuring robust pharmacovigilance systems and compliance with global safety reporting requirements. Oversee medical writing strategy and execution to ensure clarity, accuracy, and compliance across regulatory submissions, clinical study reports, and other critical documents. Ensure seamless collaboration between regulatory, PV, and medical writing functions to support integrated program execution. Cross-Functional Collaboration & Compliance Collaborate with Clinical Development, CMC, Quality, and Commercial teams to ensure regulatory and safety compliance throughout product development. Provide expert guidance to internal stakeholders on regulatory, safety, and scientific writing matters. Stay current on evolving global regulations, guidance, and industry trends, ensuring company readiness and adaptability. Operational & Financial Management Develop and manage budgets for Regulatory Affairs, Pharmacovigilance, and Medical Writing departments. Drive operational excellence, resource planning, and organizational efficiency across all functions under purview. Qualifications
Advanced Degree (PhD, PharmD, MD) in a scientific discipline or equivalent experience Minimum 15 years of progressing leadership experience in regulatory affairs and related development functions within the pharmaceutical or biotechnology industry. Proven success in late-stage drug development and regulatory approvals; strong preference for Phase 3 NDA/BLA experience. Deep knowledge of global regulatory requirements (FDA, EMA, NMPA, PMDA), pharmacovigilance frameworks, and medical writing best practices. Demonstrated success in building and leading high-performing teams, with excellent interpersonal, communication, and people management skills. Strategic, flexible thinker with a passion for mentoring talent and driving innovation. Job Level: Executive Additional Information
The base compensation range for this role is: $307,000.00-$445,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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Summary Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. We are seeking a highly experienced and dynamic Head (VP) of Regulatory Affairs and Pharmacovigilance to lead regulatory and safety strategies at the Biogen West Coast Hub (WCH). This leader will be accountable for shaping and executing comprehensive regulatory strategies to enable timely, successful interactions with global health authorities. You will lead and develop high-performing teams across Regulatory Affairs, Pharmacovigilance, and Medical Writing, fostering a culture of collaboration, scientific rigor, and operational excellence. The VP should bring both a track record of successful regulatory approvals, a passion for challenging conventional regulatory paradigms, and demonstrated leadership capability in building, mentoring, and scaling global development organizations. Responsibilities
Strategic Leadership & People Management As a key member of the West Coast Hub leadership team, provide forward-looking strategic direction and thought partnership, collaborating with cross-functional leaders to shape organizational priorities and drive long-term success. Champion a professional, inclusive, and high-performance culture where employees are valued, empowered, and heard. Manage multi-functional teams spanning Regulatory Affairs, Pharmacovigilance, and Medical Writing, ensuring that functional strategies are tightly aligned with program, portfolio, and corporate objectives. Recruit, develop, and mentor top talent, fostering a culture of accountability, innovation, and continuous growth while building strong succession pipelines for critical leadership roles. Provide a clear vision and operational discipline to ensure teams are not only executing effectively but also anticipating future needs, leveraging external market insights and internal capabilities to position the organization for sustained impact. Regulatory Strategy & Execution Develop and execute global regulatory strategies for Biogen West Coast Hub programs/molecules. Represent Regulatory Affairs at executive level governance and other decision making forums. Oversee preparation and submission of all global regulatory filings, including INDs, CTAs, Investigator’s Brochures (IBs), DSURs, NDAs, and related submissions. Mentor and lead global regulatory affairs professionals who serve as the primary point of contact for global regulatory authorities (e.g., FDA, EMA, NMPA, PMDA), leading all communications and meetings. Strategize, lead, and/or supervise the development and submission of documents/plans (e.g., Orphan, Breakthrough, Fast Track, Accelerated Approval, Diversity, Pediatric Plans) to support development goals. Drug Safety, Pharmacovigilance & Medical Writing Oversight Provide strategic direction and oversight of drug safety and pharmacovigilance operations, ensuring robust pharmacovigilance systems and compliance with global safety reporting requirements. Oversee medical writing strategy and execution to ensure clarity, accuracy, and compliance across regulatory submissions, clinical study reports, and other critical documents. Ensure seamless collaboration between regulatory, PV, and medical writing functions to support integrated program execution. Cross-Functional Collaboration & Compliance Collaborate with Clinical Development, CMC, Quality, and Commercial teams to ensure regulatory and safety compliance throughout product development. Provide expert guidance to internal stakeholders on regulatory, safety, and scientific writing matters. Stay current on evolving global regulations, guidance, and industry trends, ensuring company readiness and adaptability. Operational & Financial Management Develop and manage budgets for Regulatory Affairs, Pharmacovigilance, and Medical Writing departments. Drive operational excellence, resource planning, and organizational efficiency across all functions under purview. Qualifications
Advanced Degree (PhD, PharmD, MD) in a scientific discipline or equivalent experience Minimum 15 years of progressing leadership experience in regulatory affairs and related development functions within the pharmaceutical or biotechnology industry. Proven success in late-stage drug development and regulatory approvals; strong preference for Phase 3 NDA/BLA experience. Deep knowledge of global regulatory requirements (FDA, EMA, NMPA, PMDA), pharmacovigilance frameworks, and medical writing best practices. Demonstrated success in building and leading high-performing teams, with excellent interpersonal, communication, and people management skills. Strategic, flexible thinker with a passion for mentoring talent and driving innovation. Job Level: Executive Additional Information
The base compensation range for this role is: $307,000.00-$445,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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