AbbVie Senior Manager, Regulatory Affairs in Singapore, Singapore
Senior Manager, Regulatory Affairs
Singapore, Central Singapore, Singapore
Primary Function / Primary Goals / Objectives:
The primary function of the Senior Manager, Regulatory Affairs (RA) is to act as the representative of the regulatory affairs organization to the JAPAC commercial organization for all aspects related to the assigned therapeutic area and products of responsibility. The incumbent will define and implement the Area & Affiliate regulatory strategies and deliverables for a portfolio of compounds (late development, marketed) for the JAPAC Area. The incumbent will have knowledge of the regulatory requirements of the countries within the region and will also be the expert for regulatory aspects for a specific country or countries within the region.. The incumbent will also represent RA in any cross-functional initiatives being led out of the JAPAC commercial offices.
Primary interface to and from the RA personnel in the affiliates.
Primary interface with local health authorities via RA personnel in the affiliates.
Provides leadership and support to RA personnel in the affiliates. Assesses scientific data provided by specialist units for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps. Ensure effective presentation of data, complete and timely responses (including CTAs).
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).
Primary RA interface with Clinical Development. Represent RA on Area Immunology New Product Introduction (NPI) teams (provide strategic clinical development input from a regulatory perspective)
Designs and 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.
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, Operations, etc.) to present regulatory requirements or provide strategic input for the registration of products.
Actively supports R&D and affiliate regulatory and clinical operations teams in securing timely approval of registrational clinical trials.
Participate or lead area regulatory initiatives for JAPAC affiliates.
Ensure regulatory compliance within JAPAC for the assigned compounds/products. Implement remediation plan to address identified gaps, if any.
Education / Experience Required:
• BS degree in pharmacy, pharmacology, biology or related subject.
• Minimum 7 years’ experience in Regulatory. At least 5 years’ experience in JAPAC regulatory in new drug applications for NCEs, clinical drug development and clinical trial applications.
• Have in-depth knowledge of the regulatory requirements of the countries within the JAPAC region
• Development experience in Immunology compounds will be an advantage.
• 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.
• Ability to work independently.
Accountability / Scope:
• 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 Strategic Brand Teams for the Area.
• The incumbent is expected to communicate changes in regulatory requirements that may impact the data requirements or timelines for gaining and/or maintaining marketing authorization applications.
• The incumbent is expected to be able to 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 area commercial.
• The incumbent is expected to monitor the regulatory landscape and to identify trends within the region that make have a material impact to the business.