Senior Regulatory Affairs Executive - Singapore - Ambition

Ambition

Verified Company

Singapore

1 week ago

Posted by:

Wei Jie

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Description

Job details:

Posted 08 May 2023

SalaryNegotiable

LocationSingapore

Job type Permanent

DisciplineSupply Chain & Procurement

Reference262725_

My client is one of the key global pharmaceutical companies based in the US. They are looking to hire a
Senior Executive - Regulatory Affairs to join their growing team in Singapore.

This role would have you provide leadership and direction on regulatory activities while providing support to the country and regional business objectives and delivering pharmaceutical products and ensuring product access in the Singapore market.

Your responsibilities will include:

Develop regulatory strategies to provide support for new product registration, variations and lifecycle management and manage post approval submissions
Ensure handling of licenses, submission packages and all regulatory activities are compliant with internal regulatory processes and external local regulatory requirements.
Be responsible for maintaining uptodate records and regulatory database, understanding the local regulatory environment, and providing regulatory support on queries by internal or external parties
Provide input for product development based on the business strategy for each market and build strong partnership with different teams to help develop and implement robust regulatory processes & strategies for efficient product registration
Build and maintain professional relationships with internal and external stakeholders and Regulatory Authorities
Participate in regulatory meetings and foster an encouraging and stimulating team environment
Support Supply Chain team by strategically planning stock availability, Marketing team by providing regulatory input on promotional material and be responsible for maintaining regulatory compliance for all registered products

Key Requirements

Bachelor's/Master's degree or higher in Pharmacy, Pharmaceutical Science, or related fields. A registered pharmacist with the Singapore Pharmacy Council will be an advantage
3 years or more experience in regulatory affairs handling NDA submissions and product lifecycle management is desirable
Experienced in managing regulatory issues on time and cost effectively, knowledge about the regulatory environment of the Singapore market
Team player with effective communication, strong interpersonal and analytical skills and can work independently is desirable