Specialist Regulatory Affairs

Job Description

The Specialist is responsible for all aspects of regulatory submissions in Singapore and Brunei. Critical to this role is to combine knowledge of scientific and regulatory issues to enable new/established products that are developed, manufactured, or distributed meet the local legislations and company procedures. Managing post-marketing Lifecycle Management (LCM) activities (e.g.  change management, line extension, re-registrations, claims, labeling support) and external regulatory surveillance.  Leveraging on expertise in local regulations, Authority expectations and industry trends, this role will collaborate closely with cross-functional teams to enhance regulatory initiatives, drive regulatory compliance, and support supply continuity. The Specialist reports to Country Regulatory lead and may act as the regulatory relevant License Holder for the company.

• →Develops product registration plans and strategies and working cross-functionally to review and communicate the registration strategy with minimal oversight.
• →Timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers including but not limited to variations, renewal applications and supplemental marketing authorization in accordance with local regulations and global standards.
• →Archiving and maintenance of regulatory data and documentation in accordance with department and company policies and local requirements including, but not limited to, product licenses, import and distribution of pharmaceuticals and medical devices.
• →Ensure compliance with global and local SOPs and report any deviations or compliance concerns immediately and assist in preparing necessary corrective actions and preventive actions (CAPAs) locally for non-compliance issues.
• →Support local audits, inspections and readiness activities including audits of contractual partners/ vendors and response to findings/observations.
• →Assists in developing local procedures (in compliance with regional and global standards) for the department and evaluate processes for potential improvement in efficiency and effectiveness.
• →Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
• →May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with local Quality and Supply Chain to avoid supply constraints.
• →As delegated, ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.

• Inspires growth: Identifies and analyzes business needs in terms of capabilities, skills, behaviors, and mindsets needed.
• Delivers with accountability: Monitor regulatory trends, drives compliance, and proactively manages and mitigates risks to achieve quality outcomes.
• Innovates with agility: Demonstrates advance skills in problem solving using creative thinking, aligning with stakeholders to respond to new, complex, or problematic situations.
• Makes connections: Ability to work in partnership with others (internally and externally) to accomplish quality goals.
• Communicates with optimism and authenticity: Demonstrates advanced oral and written communications and presentation skills. Makes timely and appropriate decisions and determine when escalation of issues is necessary.
• Activates belonging: Reinforces diverse representation and consideration in development activities across teams.

• Bachelor's Degree or above in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, or a related scientific discipline. 
• Minimum 3-5 years of Regulatory Affairs experience in the pharmaceutical industry, including experience in product registrations, post-approval submissions, lifecycle management, renewals, labeling updates, and regulatory compliance activities.
• Working knowledge of Singapore pharmaceutical regulations and regulatory submission requirements is preferred.
• Demonstrated ability to interpret and apply regulatory requirements to support business objectives while ensuring compliance.
• Strong project management, planning, and organizational skills with the ability to manage multiple projects simultaneously.
• Excellent communication, influencing, and stakeholder management skills.
• Ability to work independently and collaboratively in a cross-functional and multicultural environment.
• Proficiency in Microsoft Office applications and regulatory information management systems is an advantage.

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.