Merck Group - Regulatory Affairs Manager

Position: Regulatory Affairs Manager

Location: Singapore

Reporting to: APAC Head (Regulatory Affairs)

- Manage regulatory activities to meet current and future local/regional/global Regulatory Affairs objectives in alignment with commercial objectives effectively for Singapore

- Act as the Regulatory representative and voice in the local senior management committee.

- Formulate short and long term vision for local RA function to ensure alignment within functional and other internal cross-functions at local, regional and global levels.

- Support Head of Regulatory Affairs Asia Pacific to define country specific submission strategies and to implement them locally as per plan

- Act as local expert to regional/global RA and other functions (e.g. General Management, Business Development, others), including local/regional/global management, to provide strategic input on the application of local regulations, review processes and submission requirements for Singapore.

- Maintain full awareness of all regulatory activities on local portfolio and ensures that project deadlines and performance standards for these projects are established and met.

- Ensure development, management and implementation of optimal labelling (national product information) for all products/medical device/ in Singapore, assigned throughout the product and medical device lifecycle in close alignment global labelling group and meeting corporate labelling standards, including local dissemination and artwork requests.

- Keep oversight of adequate and reliable input of marketing authorisation and compliance related data and information into corporate data bases in line with applicable internal company standards. Provide input into global database development as required.

- Ensure review and release of promotional material according to local regulations and corporate policies and procedures for portfolio in Singapore.

- Develop and implement standards to ensure regulatory compliance in line with all respective local regulations and global policies and procedures for regulatory affairs, including adequate training of local staff and third parties performing regulatory activities as requested for Singapore.

- Ensure regulatory initiatives and changes in regulatory climate are shared in timely manner with critical assessment of potential impact on business for projects assigned and proposal of risk mitigation plan where applicable by implementing a regulatory intelligence concept.

- Establish and maintain excellent working relationships with policy and decision makers within local health authority and other regulatory agencies. Proactively contribute to shape regulatory environment and to support implementation of global guidance into local regulations where possible and for Singapore.

- Act as an interface (Merck representative) with all local Health Authorities for all related regulatory affairs matters, as applicable.

- Liaise with counterparts in local industry associations and act as company's representative on industry association main committees with objective to shape local/ hub environment based on global guidance.

- Develop and manage the local departmental budget

- Monitor regulatory environment and competitor regulatory activities for Singapore, assess impact on assigned portfolio and timely communicate to internal stakeholders. Works on mitigation plan to optimize submission strategies and maximize business benefit.

- Initiate process improvements and lead implementation of best practices.

- Ensure adequate training and mentoring of employees and contractors

- Ensure maintenance of required licenses for proper functioning of the company, like GMP certificate, manufacturing license (If applicable), special functioning licenses, and provision of thereof on request

- For local products or medical device, if applicable, ensure regulatory activities for life-cycle management including evaluation and implementation of manufacturing and labelling changes

- If applicable, oversees preparation of mock-ups for submission

- Ensures selection and oversight of external vendors

- Oversees local finalization of dossiers and respective timely submission.

- Oversees maintenance and archiving of documentation in line with applicable internal company standards

Strategic Impact:

- Maintain a network of excellent relationship with Key decision Makers in Singapore; and assist GRA in all interactions with the Key Decision Makers.

- Provide submission and compliance strategies that optimize clinical development, registration and lifecycle management of the company's portfolio, taking into consideration current and regulatory requirements and standards as well as future changes in regulatory environment.

- Manage a team of regulatory professionals which is responsible for successful local authorizations and maintenance of Marketing Authorizations for the company's product and medical device portfolio

- Act as company's representative on industry association committees with the objective to shape local environment based on global guidance.

Candidates should have degree in Pharmaceutical Sciences and should be a registered pharmacist with Singapore Pharmacy Council.