Regulatory Affairs Manager, Singapore
Consultant Archita Tekriwal (R1659919)
Date posted 07 January 2019 2019-01-072019-03-08 pharmaceuticals Singapore SG SGD 100000 120000 120000 YEAR Robert Walters https://www.robertwalters.com.sg https://www.robertwalters.com.sg/content/dam/robert-walters/global/images/logos/web-logos/logo.gif
A global Top 10 Pharmaceutical company is seeking a Regulatory Affairs Manager for their Singapore business to support all regulatory activities for their products.
About the Regulatory Affairs Manager role:
An integral part of the Singapore Regulatory Affairs team, you are responsible for the development and implementation of regulatory strategies for new products and post-approval maintenance of registered products across various therapeutic areas, in alignment with core business objective.
- Prepares submission dossier for new drug applications and post-approval variations within agreed timelines as assigned
- Maintains knowledge of latest regulatory requirements for therapeutic products
- Establish and maintain good working relationship with the HSA
- Ensures new regulatory initiatives and changes are shared with the regional/global RA function in a timely manner with critical assessment of potential impact on business for the projects assigned
- Investigate regulatory compliance gaps with gap remediation plan development and implementation thereafter
- Checks and ensures promotional materials comply with local regulatory requirements and corporate policies
- Process CPP, Named Patient, and Controlled Drug Applications as and when required
- Collaborates with local Quality Assurance (QA) on Quality matters (eg implementation of safety label changes) and Drug Safety & Epidemiology (DS&E) on safety communication to HSA and RMP related matters (e.g. Singapore Specific Annex)
To be considered for this position, you must be a registered pharmacist in Singapore and have experience preparing dossiers for submission from scratch for new drug launches.
- Bachelor’s degree in health-related science, life science, Pharmacy degree
- Five years or more years of experience in regulatory affairs or related work experience
- Proven track record of preparing and reviewing regulatory documentation, and managing submissions successfully
- Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of therapeutic products
- Good understanding of local regulatory environment, guidelines and processes for product registration
- Ability to apply knowledge to general regulatory topics for projects assigned
- Computer literacy with knowledge of MS Office applications
- Good interpersonal, organizational, negotiation and problem solving skills
This company needs no introduction as it is a global Top 10 player in the pharmaceutical industry, and recognized leaders across various therapeutic areas. They have a robust pipeline of new and innovative medicines, and are looking for ambitious and growth-driven people to join them further expand the business.
If you are a progressive Regulatory Affairs professional in Singapore and keen to join a company that propels your career forward, this is the opportunity for you.
Apply now or call me to discuss this new opportunity.
Robert Walters (Singapore) Pte Ltd
ROC No.: 199706961E | EA Licence No.: 03C5451
EA Registration No.: R1659919 Archita Tekriwal