Regulatory Affairs Specialist x 3

Our client is a US MNC and a pioneering leader in the Pharmaceuticals industry. They are currently seeking three Regulatory Affairs Specialist. The successful candidate will contribute to the execution of registration strategies for medicinal products and medical devices in Singapore and Brunei to ensure timely and successful registration outcome.

Responsibilities:

• Follow regulatory processes to ensure timely regulatory filing and approval of new products, product line extensions, product labeling updates and quality-related changes.
• Ensure alignment of product availability with business plans and compliance with internal standards.
• Guide business colleagues on Singapore and Brunei registration and regulatory requirements.
• Liaise with headquarter groups on submission strategies, review and analyse the scientific contents of registration dossiers to ensure compliance with current regulatory expectations.
• Work closely with the regulatory authority to ensure successful regulatory outcomes.
• Ensure flawless implementation of the filing plans and facilitate the launch of the new/changed product.

Requirements:

• Bachelor's Degree in Life Sciences or its equivalent.
• At least 2 - 3 year of relevant commercial regulatory affairs experience and knowledge, able to work cross-functionally and independently to drive results.

Professional Competencies:

• Business and Finance Acumen: Demonstrates understanding of financial data and business facts and is able to use the data when making decisions.
• Working Across Boundaries: Demonstrates the ability to use knowledge of teams/functions to help complete tasks and projects.
• Strategic Thinking: Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
• Project Management: Demonstrates the ability to coordinate work tasks with others for timely completion and to avoid potential setbacks.
• Productive Communication: Demonstrates the ability to proactively share information through appropriate media to keep others informed.
• Problem Solving: Demonstrates the ability to evaluate data and information to determine accuracy and find potential errors.

Functional Competencies:

• Discovery & Development Knowledge: Understands the pharmaceutical business model, the end-to-end pharmaceutical lifecycle, external marketplace factors as well as regulations and standards that govern drug registration.
• Competitive Decision Making & Execution: Considers the competitor landscape, benchmarks, product benefit/risk profile and recent innovations when formulating recommendations or decisions.
• Collaboration & Partnering: Works independently with internal stakeholders to leverage the collective experience, share best practices and diversify thinking.
• Business & Operations Management: Evaluates activities and business processes, identifies areas in need of improvement and considers potential solutions or new ways of working.
• Regulatory & Compliance: Applies knowledge of company's policies/procedures and applicable industry regulations and standards to work.

If you're interested, please send in your application with your detailed and updated resume to Tammy Chew Wen Hui (R1877573) at tammy.chew@manpower.com.sg.

Thank you!

Tammy Chew Wen Hui EA License No.: 02C3423 Personnel Registration No.: R1877573

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