Executive Director, Global Therapeutic Area Lead- Anti infectives, Vaccines and Pediatrics

The Executive Director, Global Regulatory Affairs Therapeutic Area Leader- GTAL provides strategic oversight and direction for regulatory activities on a global and/or regional scale across one or more therapeutic areas. This role entails leading a multidisciplinary team in developing and executing regulatory strategies to advance our vaccine and antiviral product portfolio through all stages of development and commercialization within specific regions, such as the US, Europe, Asia Pacific...

Responsibilities include developing and implementing regulatory global strategy, driving regulatory submissions, fostering collaboration with regional colleagues, regulatory authorities and shaping/driving long-term company-wide regulatory strategies aligned with business objectives and market expansion plans. This role is also responsible for managing regulatory risks and opportunities and providing strategic guidance to executive and senior leadership. The Senior Director will serve as a key advisor on global regulatory matters, ensuring alignment with organizational goals, global and regional requirements, and best practices to achieve successful outcomes for our products in targeted markets.

In addition, The Executive Director, Global Regulatory Affairs Therapeutic Area Leader- GTAL will provide strategic oversight and direction for all pediatric regulatory activities (PIP’s, iPSP’s, etc) on a global and/or regional scale across all other Therapeutic Areas. Further, this role assumes functional responsibility for the regional therapeutic area leads across various countries.

Develop and execute global and/or regional regulatory strategies to support the development, registration, and commercialization of vaccine and antiviral products within specific regions, such as the US, EU, or Asia.

• Create a Center of Excellence for all Shionogi Global Pediatric Development/Regulatory Plans.
• Provide strategic oversight, leadership and mentorship to a multidisciplinary team of regulatory professionals, ensuring alignment with company objectives and regional regulatory requirements.
• Drive the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications, Biologics License Applications (BLAs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs), to regulatory authorities for a portfolio of complex global products.
• Champions and influences cross-functional teams, including R&D, clinical development, manufacturing, and commercial functions, to ensure regulatory compliance and alignment of regulatory activities with product development milestones.
• Manage high-level relationships with global/regional regulatory authorities, including the FDA, to facilitate communication, negotiations, and interactions related to regulatory submissions and approvals, as well with industry leaders to shape policy and influence strategy.
• Monitor regulatory developments, changes, and trends within specific regions, assessing their impact on product development and commercialization strategies, and provide strategic guidance to executive leadership.
• Manage regulatory risks and opportunities, proactively identifying potential obstacles to regulatory approval or compliance and developing mitigation strategies to address them.
• Provide Global Project Teams with regulatory guidance and support for post-marketing activities, including variations, renewals, labeling updates, and compliance initiatives, to maintain product registrations and ensure ongoing regulatory compliance.
• Represent the company's interests in industry forums, working groups, and regulatory meetings, advocating for regulatory policies and positions that support product development and commercialization objectives.
• Serve as a subject matter expert on global regulatory requirements, guidelines, and best practices, providing training, mentorship, and guidance to regulatory team members and cross-functional stakeholders.
• Collaborate with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.
• Prepare and present regulatory updates, progress reports, and strategic recommendations to senior and/or executive leadership and regulatory governance committees, informing decision-making and driving regulatory excellence within the organization.
• Other duties as assigned.

Minimum Job Requirements

Qualifications

• Bachelor's degree in a scientific discipline such as life sciences, pharmacy, medicine, bioscience; advanced degree (MD, PhD) preferred.
• 12+ years of experience in regulatory affairs within the pharmaceutical / biotech industry or Regulatory Agencies with a focus on vaccine and/or antiviral products required.
• Proven track record of successful leadership and management of teams, with demonstrated ability to develop and execute regulatory strategies, drive regulatory submissions, and achieve regulatory approvals.
• Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines, with experience in interacting with regulatory authorities.
• Extensive experience in pediatric regulatory activities, including Pediatric Investigation Plans (PIPs) and Initial Pediatric Study Plans (iPSPs), as well as expertise in antiviral therapeutic areas, is required to effectively manage and oversee global regulatory strategies and submissions.
• Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across functions and regions.
• Strategic mindset with the ability to anticipate challenges, identify opportunities, and develop innovative solutions to achieve regulatory objectives.

Competencies

• Ability to develop and execute regulatory strategies tailored to specific regions, taking into account regional regulatory requirements, guidelines, and best practices.
• Strong leadership skills with the ability to effectively lead and motivate a multidisciplinary team, foster collaboration, and drive results in a fast-paced and dynamic environment.
• Proficiency in preparing and submitting regulatory documents, including INDs, BLAs, NDAs, and MAAs, to regulatory authorities, with a thorough understanding of regulatory submission requirements and processes.
• Keen awareness of regulatory developments, changes, and trends within specific regions, with the ability to analyze their impact on product development and commercialization strategies and provide strategic guidance to executive leadership.
• Strong interpersonal and communication skills with the ability to effectively engage and collaborate with internal stakeholders, cross-functional teams, and external regulatory authorities to achieve regulatory objectives.
• Ability to identify regulatory risks and opportunities, proactively assess their potential impact on regulatory approval or compliance and develop mitigation strategies to address them effectively.
• Experience in preparing teams for regulatory inspections, managing interactions with regulatory inspectors, and leading post-inspection activities to address inspection findings and ensure compliance with regulatory requirements.

Other Requirements

• This position has significant leadership responsibilities as it pertains to global project teams and decision-making authority.

To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.

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