Regulatory Affairs Manager

18 hours ago

Singapore HEALTHCARE CAREER GROOVE PTE. LTD. Full time

**Job Summary
We are looking for a Regulatory Affairs Manager to join our team and help us ensure that our drug and medical device products are compliant with national and regional regulations in Southeast Asia. In this role, you will be responsible for developing and implementing regulatory strategies, overseeing the regulatory submission plan, and managing regulatory operations. You will also collaborate with internal departments and external agencies to ensure regulatory compliance and facilitate product registrations and launches.

**Responsibilities**
- Develop and implement regulatory strategies for new products and changes to existing products in line with business objectives.
- Ensure regulatory compliance throughout the product life cycle, including license renewals and life cycle management.
- Ensure dossiers (ICH/ACTD) or technical files comply with international regulatory standards for submission to regulatory authorities in Southeast Asia.
- Manage the compilation and submission of responses to queries raised during the evaluation of registrations through coordination with relevant parties.
- Liaise on regulatory activities required for new product launches based on commercial needs, including redressing activities and promotional material reviews to ensure alignment with brand guidelines and registered product details.
- Manage compliance of product labels and liaise with the supply chain for implementation in commercial shipments in Southeast Asia.
- Maintain strong relationships with regulatory authorities and trade associations to ensure a smooth and efficient registration process.
- Liaise with internal departments (Production, R&D, QA) and external agencies (health authorities in Southeast Asia) for regulatory operations.
- Stay up to date on regulatory changes in the Southeast Asia region.
- Collate information from the region for periodic safety updates reports.
- Continuously develop regulatory knowledge and expertise to effectively perform the role.
- Perform any other ad-hoc duties as and when assigned by the Company.

**Qualifications**
- Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degree is a plus.
- At least 10 years of experience in regulatory affairs within the pharmaceutical industry, with a focus on Southeast Asia.
- Strong understanding of national and regional regulatory requirements for drug and medical device products.
- Familiarity with international regulatory standards (ICH/ACTD) and good knowledge of regulatory compliance for product labels and promotional materials.
- Excellent stakeholder management and communication skills, with the ability to work collaboratively across internal and external functions.
- Proven ability to develop and maintain positive relationships with regulatory authorities and trade associations.
- Detail-oriented mindset with strong organizational and project management skills.
- Ability to adapt to changing regulatory environments and prioritize tasks effectively.
- Proficiency in English and knowledge of local languages within Southeast Asia is advantageous.

**This is a challenging and rewarding role for a highly motivated and experienced Regulatory Affairs professional. If you are looking for an opportunity to make a real impact on the healthcare industry, we encourage you to apply.

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