Job Summary (Primary function) The Senior Manager/ Associate Director, International Regulatory Affairs - Lifecycle Management will be an International Strategy Lead playing a critical role within the Regulatory Affairs International department, ensuring the seamless Life Cycle Management (LCM) of key pharmaceutical products addressing critical unmet medical needs. This position is accountable for maintaining the continuous supply of these essential treatments while navigating complex regulatory landscapes to support line extensions, post-approval changes, and labeling updates. Essential Functions of the Job (Key responsibilities) - Lead the creation, review, and submission of regulatory documents, ensuring compliance with global regulatory standards across the international region, ensuring a collaborative and inclusive environment.
- Review regulatory submission materials (e.g., MAA, HA Meetings, Orphan Designations) to ensure accuracy, timeliness, completeness, and alignment with regulatory standards.
- Ensure consistency across all components of submissions, including technical, nonclinical, and clinical data.
- Prepare and present dossiers clearly and succinctly to facilitate regulatory review and approval.
- Collaborate with internal and external stakeholders to address technical and strategic aspects of submissions.
- Monitor and ensure compliance with global regulatory requirements, internal policies, and evolving guidance.
- Proactively update internal processes to reflect changes in the international laws, regulations, and standards.
- Coordinate and lead the preparation of responses to regulatory authority questions and inquiries.
- Act as the primary liaison with health authorities, through teleconferences, meetings, and written communication.
- Develop and implement global regulatory strategies to support LCM activities, including line extensions, post-approval variations, and labeling updates, ensuring uninterrupted product supply for critical unmet medical needs.
- Ensure accurate retention and management of regulatory submissions, communications, and documentation in archival systems, maintaining accessibility and compliance.
- Lead cross-functional and matrixed teams, promoting effective communication, collaboration, and alignment with shared objectives to support regulatory submissions and LCM strategies.
- Advocate for streamlined regulatory processes and continuous learning to improve timelines, quality, and operational efficiencies.
- Offer expert advice to internal teams, senior management, and external stakeholders on regulatory strategy, compliance, and submission processes.
- Utilize document management systems and electronic submission tools (e.g., eCTD) to efficiently manage regulatory files, ensuring compliance with submission requirements.
- Demonstrate strong analytical, organizational, and interpersonal skills, influencing others positively and effectively. Manage multiple projects in a deadline-driven environment.
Qualifications (Minimal acceptable level of education, work experience, and competency)
• Bachelors or advanced degree (Ph.D. or Pharm.D.). Scientific/life-sciences degree a plus. Regulatory Affairs (RAC) Certification is a plus. • A minimum of 5 years’ experience in international regulatory affairs or related experience, as applicable. - Knowledge of pharmaceutical drug development, and regulations/guidelines governing development of pharmaceuticals.
- Hands-on experience with post-approval changes, authoring regulatory documents, and compliance with global regulatory requirements.
• Proven ability to collaborate in matrixed, global teams and effectively liaise with health authorities and internal stakeholders. • Demonstrated success in managing cross-functional projects and driving alignment across global, regional, and local teams. • Strong analytical skills to assess risks, deliver solutions, and ensure regulatory compliance. - Experience with products addressing critical unmet medical needs, orphan drugs, or diverse market regulations.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Learn more at: During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process . |
