Regulatory Affairs Manager (Pharmaceutical | Biology | $8000)
12-Months Contract (Renewable)
Location: Buona Vista
Salary: Up to $8000 depending on experience
Our client, a MNC company in BioPharmaceutical Industry located in the Central is currently looking for Regulatory Affairs Manager.
Primary Function / Primary Goals / Objectives:
- The primary function of the 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 projects within the Immunology therapeutic area. The incumbent will have knowledge of the regulatory requirements of the countries within the region. The incumbent will also represent RA in any cross-functional initiatives being led out of the JAPAC commercial offices.
- Supports JAPAC affiliates and Global Regulatory Affairs in Marketing Authorization (MA) related activities for the assigned projects
- Manages interface with Affiliate/Agency for key projects/issues, including direct/ indirect negotiation with regulatory agencies.
- Implements regulatory strategies for assigned projects for countries in JAPAC region in line with area commercial priorities in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
- Partners with JAPAC commercial area to ensure business needs are met.
- Represents the JAPAC regulatory function at sub-teams to present regulatory requirements or provide strategic input for the registration of products.
- 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.
- Manages lifecycle activities for the assigned projects to ensure regulatory requirements are met
- Accountable for representing RA to the area commercial organization and ensuring that commercial priorities are communicated and integrated into the global regulatory strategies.
- Acts as the representative for RA on the Strategic Brand Teams for the Area.
- Expected to communicate changes in regulatory requirements that may impact the data requirements or timelines for gaining and/or maintaining marketing authorization applications.
Education / Experience Required:
- BS degree in pharmacy, pharmacology, biology or related subject.
- Minimum 5 years' experience in Regulatory.
- Have in-depth 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.
- Proficiency in communicating strategic and tactical issues to management.
If you possess above relevant skillsets, please send in your updated CV in word format to Apple.email@example.com
Lim Pey Chyi
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579