Singapore Regulatory Executive
A large biopharmaceutical company in search for a talented Regulatory Executive to assume primary responsibility in providing regulatory support. The role based in Singapore will require the Regulatory Executive to undertake project management and ensure regulatory compliance at all times.
- Planning, preparing and submitting new marketing authorization applications for Singapore
- Planning, preparing and submitting post approval changes including variations, change notifications,
renewals etc. for Singapore
- Liaise with the local authorities to ensure timely regulatory approvals
- Perform regulatory assessments on potential new products
- Develop regulatory strategies during the preparation of new application, renewal and variation
submissions to address gaps and communicate its impact
- Review and approve labels and artwork for regulatory compliance
- Process and report product quality complaints/product defect to the authority, Regional and/or
- Liaise with distributor on the secondary repackaging requirements
- Serves as the Local Drug Safety Unit Deputy and ensure timely adverse event reporting to the
authority, Regional and/or Partners
- Maintain database of registrations and status, product quality complaints and adverse events
- Support Regulatory Manager in maintaining Good Distribution Practice/ GDPMDS, audits and other
relevant RA and QA matters
- Review promotional materials in relation to product campaign launches and ongoing product
Skills and Requirements
- Candidate must possess at least a Bachelor's Degree preferably in Pharmaceutical Science or Pharmacy
- Candidate must be a current pharmacy certificate license holder with the Singapore Pharmacy Council
- Strong regulatory background with at least 2 years of experience preferably in Healthcare products - or equivalent.
- Preferably with regulatory experience in therapeutic products, medical devices, cosmetics and/ or health supplement.
- A team player and proven interpersonal skills
- Ability to influence and collaborate with people at all levels effectively
- Proficient in both oral and written English
- Computer literate
- Attention to details and results oriented
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.