The PositionThis 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 StrategyManage 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 InteractionKeep 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 SupportProvide regulatory consultation and collaborate with local business stakeholdersEnsure that product promotion in the market complies with local and global regulatory frameworks to sustain and expand the businessParticipate in the promotional material approval process to ensure regulatory complianceProvide feedback to global teams and participate in global initiatives when required4. Quality and ComplianceEnsure timely submission of CCDS updates, CRC changes, renewals, PSURs, and other local variations in compliance with internal KPIsMaintain regulatory databases to reflect current registration status and regulatory requirementsEnsure that timelines for regulatory review in the e-MLR process are met and that promotional materials comply with local regulationsContribute to audits, CAPA processes as appropriate, and support local inspection readinessArchive local regulatory submission documents in accordance with internal standards5. Deputy Role and Training Support to Local RA TeamFulfill the responsibilities of the Head of Regulatory Affairs in their absenceAct as a mentor by providing guidance and actively training other team members in regulatory tasks, where appropriateRequirements:Bachelor's degree; Degree in Pharmacy preferredOver 7 years of experience in the pharmaceutical, medical device, or healthcare industryBackground in regulatory affairs or a related discipline is an advantageSolid understanding of drug development and national regulatory proceduresTechnical expertise in at least one therapeutic or regulatory area (e.g., CMC, clinical)Proven ability to interact with health authorities and navigate local regulatory requirementsStrong communication skills for both internal and external stakeholdersProficient in English (written and verbal)Comfortable working with databases; strong computer literacyEffective in cross-functional, matrix environmentsProactive, assertive, and collaborative team player
