The Senior Director, Regulatory Affairs - GDP provides strategic oversight and direction for regulatory activities on a regional and/or global scale. This role entails leading a multidisciplinary team in developing and executing regulatory strategies to advance our vaccine and bacterial product portfolio through all stages of development and commercialization within specific regions, such as the US. Responsibilities include developing and implementing regulatory strategy, driving regulatory submissions, fostering collaboration with regional regulatory authorities, managing regulatory risks and opportunities, and providing strategic guidance to executive and senior leadership. The Senior Director will serve as a key advisor on regulatory matters, ensuring alignment with company goals, regional requirements, and best practices to achieve successful outcomes for our products in targeted markets.

RESPONSIBILITIES

• Develop and execute regional regulatory strategies to support the development, registration, and commercialization of vaccine and bacterial products within specific regions, such as the US.
• Provide strategic oversight and leadership 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.
• Collaborate with 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.
• Foster relationships with regional regulatory authorities, including the FDA, to facilitate communication, negotiations, and interactions related to regulatory submissions and approvals.
• 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 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 regional 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, bioscience; advanced degree preferred.
• 12 years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on vaccine and/or bacterial 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.
• 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 managerial and decision-making authority.
• Ability and willingness to travel approximately __% of the year both domestically and internationally
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month

ESSENTIAL PHYSICAL REQUIREMENTS 

• Ability to articulate clearly and conduct verbal presentations with large and small audiences.
• Ability to travel via automobile and/or airplane.
• Ability to view video display terminal images < 18” away from face for extended period of time – up to four (4) hours at a time.
• Ability to operate a computer keyboard and telephone.
• Ability to sit for extended periods of time – up to four (4) hours at a time.
• Ability to lift, tug, pull up to fifteen (15) pounds.

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

Disclaimer

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. 

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.

EEO Statement

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.