Senior Regulatory Affairs Executive

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 up-to-date 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

If you believe you fit the requirements for the role, please click APPLY NOW or you can email your CV to mohit.surana@ambition.com.sg

Data provided is for recruitment purposes only. Business License Number: 10C5117. EA Registration Number: R22110278. Regrettably, only shortlisted candidates will be notified.

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