PRIMARY FUNCTION/OBJECTIVE:

The primary function of the Senior Manager, Regulatory Affairs (RA) is to act as the primary representative of the regulatory affairs organization for all aspects related to the assigned therapeutic area. The role will cover cross Therapeutic Area (Neuroscience, Eyecare & Specialty) products of responsibility in JAPAC (Australia, China, Japan, and Asia). The incumbent will have knowledge of the regulatory requirements of the countries within the region, and will combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The incumbent will also represent RA in any cross-functional initiatives being led out of the Intercontinental commercial office.

CORE JOB RESPONSIBILITIES:

Lead and execute regional Regulatory Affairs (RA) initiatives for JAPAC in partnership with global, area, and affiliate teams; ensure timely project completion and efficient communication and implementation of plans.
Serve as the primary RA liaison to affiliate teams for assigned programs, maintaining clear and productive communication channels.
Serve as primary RA point of contact with local health authorities (through affiliate RA personnel); prepare teams for agency consultations by aligning briefing materials with the regulatory strategy, and ensure outcomes are communicated promptly to stakeholders.
Assess and review scientific and technical data provided by subject matter experts for regulatory submissions, ensuring alignment with JAPAC and regional requirements, identifying gaps, and developing mitigation strategies as needed.
Effectively present regulatory data to RA affiliates and ensure complete and timely responses to authorities for Clinical trial applications, New Drug/ New indication applications and any other assigned applications.
Collaborate cross-functionally with Commercial, Medical Affairs, Market Access, Clinical Development, and CMC teams, represent the regulatory function and provide strategic input to enable product registrations, mitigate regulatory risks, and ensure compliance.
Develops Area Regulatory Strategy and implements Regulatory Plan for assigned projects in JAPAC region in conjunction with the Global Regulatory Lead, RA Affiliate team and RA submission management.
Represent regional and affiliate regulatory strategies and requirements in Global Regulatory Product Teams (GRPT), ensuring alignment across global, regional, and local stakeholders and regulatory leadership forums.
Monitor and analyze trends in the regional regulatory environment and emerging policies; provide updates, assess business implications, and develop strategies to address regulatory changes affecting product portfolios.
Support R&D, affiliate regulatory teams, and clinical operations in achieving timely approvals for clinical trials applications.
Oversee regulatory compliance for assigned products/compounds in JAPAC; support implementation and monitoring of remediation plans to address identified compliance gaps.
Proactively identify, escalate, and manage regulatory risks throughout the product life cycle, recommending solutions to management as required.
May participate in due diligence, portfolio planning, or integration activities to support business expansion or product acquisitions.
Contribute to process improvement initiatives within the RA function and foster a culture of continuous improvement, knowledge sharing, and best practices.

Accountability / Scope:

The incumbent will:
- manage assigned compounds and projects
- ensure prioritization of regulatory plans and execute those in line with business priorities.
The incumbent is accountable for representing RA to the area commercial organization and ensuring that commercial priorities are communicated and integrated into the global regulatory strategies.
The incumbent acts as the representative for RA on the cross-functional teams for the Area.
The incumbent is expected to communicate changes in regulatory requirements and provide comprehensive impact assessments on how these changes affect the data requirements or timelines for gaining and/or maintaining marketing authorization applications.
The incumbent is responsible to ensure regulatory compliance for the assigned compounds/ products.

Problem Solving:

The incumbent is expected to be able to proactively identify potential issues that may impact the regulatory strategy and timeline for products of responsibility and to develop solutions to mitigate the risk and outcome.
The incumbent should have strong communication and negotiation skills in order to be able to reach mutually agreeable solutions on issues with regulatory agencies, affiliates and Intercontinental commercial.
The incumbent is expected to monitor the regulatory landscape and to identify trends within the region that may have a material impact to the business.

Qualifications

Education / Experience Required:

Bachelor’s degree in pharmacy, Pharmacology, Biology, or a related scientific discipline (advanced degree preferred).
Minimum of 7 years’ experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with at least 5 years’ hands-on experience in JAPAC regulatory affairs, end to end experience with both Japan and China New Drug Registrations, Health Authority Interactions and Clinical Trial Applications, with strong sensitivity and understanding of the cultural and business practices across the JAPAC region.
Comprehensive knowledge of the regulatory requirements and processes across JAPAC countries, with demonstrated expertise in navigating local regulations, submissions, and health authority interactions.
Early development experience beginning with Phase 1 clinical trials, including exposure to adaptive clinical trial designs.
1-2 years of Regulatory experience with medical devices or combination products would be an advantage.
Experience working with Neuroscience, Eyecare and Specialty compounds is preferred.
Solid business acumen developed through participation in cross-functional projects and assignments.
Demonstrated interpersonal and influencing skills, with a proven ability to communicate strategic and tactical regulatory issues clearly to management and diverse stakeholders.
Strong personal development and motivational skills; committed to ongoing professional growth and supporting the growth of others.
Ability to work independently, manage multiple priorities, and deliver high-quality outcomes in a dynamic, fast-paced, and cross-cultural environment.

Additional Information

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