Title Regulatory Affairs Specialist

ProductLife Group; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A consulting company in Singapore is seeking a Regulatory Affairs Specialist to ensure compliance with international regulations for pharmaceutical products. This role involves managing the submission and approval processes, acting as a liaison with regulatory agencies, and staying updated on relevant guidelines. The ideal candidate has 5-8 years of experience in Regulatory Affairs and expertise in submission processes, particularly with European Regulatory Authorities.

Qualifications

• 5-8 years of relevant experience in Regulatory Affairs internationally.
• Expertise in Manufacturing License Application (MLA), Marketing Authorization Applications (MAA).
• Experience with European Regulatory Authorities is essential.

Responsibilities

• Ensure compliance with regulatory requirements for pharmaceutical products.
• Manage submission and approval processes for various applications.
• Act as a liaison between the pharmaceutical company and regulatory agencies.

Skills

Communication

Organizational Skills

People Management

Analytical Skills

Coordination

Tools

Microsoft Office Suite

Veeva Vault

Trackwise

Job description

We are looking for a highly motivated and detail-oriented individual to join our consulting company as a Regulatory Affairs Specialist. Your primary responsibility will be to ensure compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally.

Key Responsibilities

1. Manage submission and approval processes for applications such as Manufacturing License Application (MLA), Technical/Site Transfer Applications, and Marketing Authorization Applications.
2. Prepare and submit documentation for post-approval applications and ensure compliance with regulatory processes during internal and external audits.
3. Stay updated on national, European, and international guidelines/legislation, ensuring compliance within assigned regions.
4. Act as a liaison between the pharmaceutical company and regulatory agencies.
5. Support internal requests for information and work on lifecycle maintenance activities.

Qualifications

• 5-8 years of relevant international experience in Regulatory Affairs.
• Expertise in MLA, MAA, CTD, Variations, Renewals, and Labeling Applications.
• Experience working with European Regulatory Authorities.
• Familiarity with software such as Microsoft Office Suite, Veeva Vault, LorenZ, Trackwise, and PromoMat.
• Strong organizational and communication skills.
• Ability to prioritize tasks effectively.
• Experience in people management/coordination and promotional/non-promotional activities is a plus.

Additional Skills

• Knowledge of US FDA and EU regulations, including Labeling, CMC, and electronic submission standards.
• Proficiency in document management systems, data analysis, and negotiation.
• Excellent presentation and analytical skills.

If you are passionate about regulatory affairs and eager to make a significant impact, we encourage you to apply for this exciting opportunity.