*NEW* Senior Regulatory Affairs Executive (2 years contract)

Ambition Group Singapore Pte. Ltd. (SG); Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Regulatory Affairs professional to support submission processes and compliance in emerging markets. This role includes strategic development of regulatory strategies, internal collaboration, and stakeholder engagement to ensure timely approvals. Candidates should possess 3–5 years of relevant experience, particularly in managing NDA processes and understanding regulatory environments.

Qualifications

• 3–5 years of experience in regulatory affairs and NDA processes.
• Strong knowledge of regulatory environments in Sri Lanka, Nepal, Mongolia, Bangladesh.
• Understanding of pharmaceutical industry practices.

Responsibilities

• Develop and implement regulatory strategies for site transfers and new registrations.
• Review and coordinate submissions to ensure compliance with local regulations.
• Collaborate with internal teams and external partners.

Skills

Regulatory Affairs

Compliance

Communication

Analytical Skills

Job description

This role will support the Head of Regulatory Affairs in managing regulatory submissions for site transfers and product registrations in emerging markets. This role involves cross-functional collaboration, stakeholder engagement, and strategic input into regulatory processes to ensure compliance and timely approvals.

Key Responsibilities:

• Develop and implement regulatory strategies for site transfers, new registrations, variations, and lifecycle management.

• Review and coordinate submissions, ensuring compliance with local regulations.

• Maintain regulatory systems and databases accurately.

• Collaborate with internal teams (commercial, medical, supply chain) and external partners (distributors/MAHs).

• Monitor local regulatory trends and provide intelligence and guidance to internal stakeholders.

• Support stock availability and regulatory input for marketing and product launches.

• Ensure compliance with SOPs and regulatory requirements.

• Participate in process improvement initiatives and manage ad-hoc projects.

Qualifications:

• 3–5 years of regulatory affairs experience, including NDA processes and lifecycle management.

• Strong knowledge of regional regulatory environments (Sri Lanka, Nepal, Mongolia, Bangladesh).

• Proven ability to deliver high-quality regulatory work on time.

• Fluent in English with strong communication and analytical skills.

• Understanding of pharmaceutical industry practices and financial considerations.

If you have what it takes, please send your resume to [e-mail] or click APPLY NOW. For more information, please visit www.ambition.com.sg. Data provided is for recruitment purposes only. Regrettably, only shortlisted candidates will be notified. Business Reg No : 200611680D | Licence No : 10C5117 | EA Reg No : R2199023