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.
Qualifications
Minimum Job Requirements
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.
Job Identifier: #5024
Seniority level
Director
Employment type
Full-time
Job function
Quality Assurance
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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