Specialist, Regulatory Affairs

Job Description

The Specialist is responsible for all aspects of regulatory submissions Malaysia. 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.

Competencies

• →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: Encourages diverse thinking and experiments with new ways of working to respond to new, complex, or problematic situations.
• →Makes connections: Ability to work in partnership with others (internally and externally) to accomplish quality goals; leads integrated projects and build effective networks.
• →Communicates with optimism and authenticity: Demonstrates good oral and written communications and presentation skills. Determine when escalation of issues is necessary.
• →Activates belonging: Reinforces diverse representation and consideration in all talent selection and development activities across teams.

• Minimum of 2 to 5 years of industry experience in regulatory affairs in Local or MNC pharmaceutical company
• The incumbent must have a University Degree, B.Sc. or higher in Health Sciences (including chemistry, biochemistry, physiology) or equivalent.
• Local registered pharmacist is required.
• He/she must have a sound knowledge of regulations within the assigned markets and be an expert in local regulatory processes and activities.
  

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.