Regulatory Affairs Manager, MSI

The Position  

This role is responsible for leading timely and successful product registrations in alignment with both corporate objectives and local regulatory requirements. It plays a critical part in ensuring full compliance with applicable laws, guidelines, and industry standards governing the importation, licensing, and control of therapeutic products. 

You are require to collaborate with internal stakeholders and health authorities to navigate regulatory pathways efficiently and effectively. In addition to managing submissions and approvals, the role contributes strategic input to regulatory planning, supports cross-functional initiatives, and helps shape local regulatory strategies that enable market access and long-term business sustainability. 

Duties and Responsibilities:  

1. Regulatory Planning and Submission Strategy 

• Manage all regulatory tasks and projects, including obtaining and maintaining product and operational licenses for the assigned portfolio on behalf of BI, as required by local regulations. 

• Prepare and submit regulatory applications for the assigned portfolio, ensuring timely approvals. 

• Develop local registration plans in alignment with local business objectives and global regulatory strategy. 

• Monitor the progress of submissions and coordinate timely responses to all questions from health authorities for the assigned portfolio. 

• Ensure compliance with corporate policies, regulations, and procedures, particularly the implementation of the current Company Core Data Sheet (CCDS), Change Review Committee (CRC), and local change control procedures. 

• Manage regulatory submissions to support clinical trial activities in the OPU, if applicable. 

2. Regulatory Intelligence and Interaction 

• Keep the local Regulatory Affairs (RA) team and ROPU informed of new regulations or updates. 

• Ensure timely regulatory impact assessments. 

• Maintain close relationships with relevant health authorities and other organizations/key stakeholders to facilitate and develop effective collaboration on regulatory interactions. 

• Communicate with health authorities and local industry groups on regulatory issues. 

3. Cross-Functional Collaboration and Support 

• Provide regulatory consultation and collaborate with local business stakeholders 

• Ensure that product promotion in the market complies with local and global regulatory frameworks to sustain and expand the business 

• Participate in the promotional material approval process to ensure regulatory compliance 

• Provide feedback to global teams and participate in global initiatives when required 

4. Quality and Compliance 

• Ensure timely submission of CCDS updates, CRC changes, renewals, PSURs, and other local variations in compliance with internal KPIs 

• Maintain regulatory databases to reflect current registration status and regulatory requirements 

• Ensure that timelines for regulatory review in the e-MLR process are met and that promotional materials comply with local regulations 

• Contribute to audits, CAPA processes as appropriate, and support local inspection readiness 

• Archive local regulatory submission documents in accordance with internal standards 

5. Deputy Role and Training Support to Local RA Team  

• Fulfill the responsibilities of the Head of Regulatory Affairs in their absence 

• Act as a mentor by providing guidance and actively training other team members in regulatory tasks, where appropriate 

Requirements:  

• Bachelor’s degree; Degree in Pharmacy preferred 

• Over 7 years of experience in the pharmaceutical, medical device, or healthcare industry 

• Background in regulatory affairs or a related discipline is an advantage 

• Solid understanding of drug development and national regulatory procedures 

• Technical expertise in at least one therapeutic or regulatory area (e.g., CMC, clinical) 

• Proven ability to interact with health authorities and navigate local regulatory requirements 

• Strong communication skills for both internal and external stakeholders 

• Proficient in English (written and verbal) 

• Comfortable working with databases; strong computer literacy 

• Effective in cross-functional, matrix environments 

• Proactive, assertive, and collaborative team player