You are here
REGULATORY AFFAIRS SPECIALIST
A Leading Pharmaceutical Company
Regulatory Affairs & Pharmacovigilance Specialists who have 1 year experience
About Our Client
Our client is one of the leading pharmaceutical companies. For their future development plans we are looking for a :
REGULATORY AFFAIRS & PHARMACOVIGILANCE SPECIALIST (Niche Area)
Reporting to Regulatory Affairs Manager, the ideal candidate will be responsible for:
-Supporting development of regulatory affairs strategies;
-Maintaining all regulatory business relations and enhancing them;
-Being responsible for submission and follow up of registration dossiers with Ministry of Health for all new products and renewals in compliance with the relevant product regulations;
-Being responsible for pharmacovigilance;
-Ensuring the content and quality of all regulatory documentation is adequate and sufficient to meet market regulatory requirements;
- Preparing GMP inspection submissions and attend GMP inspections with the inspectors, follow-up certification process;
- Responding to Health Authority requests and questions on product registrations;
- Keeping the company update in terms of worldwide regulatory requirements and International Standards;
- Being responsible for review of product labelling to ensure compliance with all labelling/advertising regulations;
- Conducting oneself consistent with company standards at all times during work hours or when acting as a representative of the company.
The Successful Applicant
Th successful candidate is required to have Bachelor's Degree in Pharmacy. 1 or 2 years of experience of Regulatory Affairs in Pharmaceutical industry is a strong asset. Extensive understanding of principles, concepts, practices and standards of Regulatory Affairs and Pharmacovigilance functions is required. Analytic and result-oriented profiles would be strongly preferred. Ideal candidates should also have proficiency in MS Office Applications and fluency in English.
What's on Offer
Join a corporate company to evolve in your career.