Specialist Regulatory Affairs

9031 Organon Asia Pacific Services Pte Ltd; Singapore; On-site; SGD 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work arrangement

Flexible work arrangements

No relocation required

Job summary

Organon LLC in Singapore seeks a Regulatory Specialist to manage local regulatory submissions and lifecycle activities. You will collaborate with cross-functional teams to ensure compliance with local authorities and global standards, enabling timely registrations and renewals.

The role requires 3–5 years in regulatory affairs, strong project management, and knowledge of Singapore regulations. Hybrid work arrangements are supported, with a focus on ensuring supply continuity and regulatory

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences or related field.
• 3–5 years in regulatory affairs in pharma, with lifecycle management.
• Knowledge of Singapore regulations and submission requirements.
• Strong project management and stakeholder skills.

Responsibilities

• Develops product registration plans and strategies.
• Prepare and submit marketing authorization applications to local authorities.
• Maintain regulatory data and documentation per policies.
• Ensure SOP compliance and implement CAPAs locally.
• Support audits, inspections, and vendor responses.
• Identify process improvements with stakeholders.

Skills

Regulatory affairs

Project management

Communication

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Pharmacy or Life Sciences

Tools

Regulatory systems

Job description

Position

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.

Responsibilities

• 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.

Competencies

• Inspirers 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.

Requirements

• 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.

Who We Are

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.

Benefits & Details

• Employee Status: Regular
• Relocation: No relocation
• VISA Sponsorship: No
• Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
• Flexible Work Arrangements: 10% Flexible Work Arrangements
• Hybrid Shift: Hybrid Shift
• Valid Driving License: No
• Hazardous Material(s): None
• Number of Openings: 1

Additional Information

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.