Manager, Regulatory Affairs

The primary function of the Manager, Regulatory Affairs (RA) is to act as the 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:

• Primary interface to and from the RA personnel in the affiliates.
• Primary interface with local health authorities via RA personnel in the affiliates.
• Primary RA interface with Commercial. Represent RA on area brand teams (provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product).
• Implements Area Regulatory Strategic Tactical Plan for assigned projects for countries in JAPAC region in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
• Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met.
• Maintains, monitors and provides input on the regional regulatory environment and policies to understand new regulations, assess implications to the business, develop and execute strategies to respond to the regulations.
• Represents the JAPAC regulatory function at sub-teams or client group meetings (i.e. commercial R&D, CMC, etc.) to present regulatory requirements or provide strategic input for the registration of products.
• Actively supports affiliate regulatory in securing timely approval of registrational clinical trials.
• Actively participates in training programs and other area regulatory initiatives for JAPAC affiliates.
• Ensure regulatory compliance for the assigned compounds/products. Implement remediation plan to address identified gaps, if any.

Accountability / Scope:

• The incumbent is responsible to provide support to RA personnel in the affiliates to support the registration of the products in the assigned therapeutic area in a timely manner.
• The incumbent acts as the representative for RA on the strategic brand teams for the area.
• 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 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.
• The incumbent works on assigned work processes to achieve the program objectives established by senior management.

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.

Requirements

• BS degree in pharmacy, pharmacology, biology or related subject.
• Minimum 5 years’ experience in Regulatory. At least 3 years’ experience in JAPAC regulatory affairs. Have knowledge of the regulatory requirements of the countries within the JAPAC region
• Sensitivity/knowledge of JAPAC culture and ways of doing business is helpful.
• Proven interpersonal skills.
• Strong proven personal development and motivational skills.
• Proficiency in communicating strategic and tactical issues to management.