Specialist, Regulatory Affairs

organon; Philippines; On-site; PHP 900,000 - 1,200,000; Full time

Job summary

Organon Philippines is seeking a Regulatory Specialist who will oversee submissions and lifecycle management to ensure compliance with local regulations and company standards. You will work across cross‑functional teams to drive registration strategies, coordinate post‑market dossiers, and support supply continuity while upholding regional and global SOPs.

The ideal candidate has 3–5 years in regulatory affairs/CMC, is a locally registered pharmacist, and holds a B.Sc.

Qualifications

• 3–5 years of regulatory affairs/CMC experience in MNC or local market.
• Local registered pharmacist is required.
• Strong knowledge of local regulations and regulatory processes.
• University degree in Health Sciences or equivalent.

Responsibilities

• Drive regulatory submissions strategies and coordinate cross‑functional execution.
• Prepare and submit new marketing authorization applications and post‑market dossiers.
• Maintain regulatory data and documentation per SOPs and local requirements.
• Ensure compliance with global/local SOPs and assist CAPA when needed.
• Support audits, inspections and readiness activities with contraction partners/vendors.
• Identify gaps and drive improvements in regulatory processes.

Skills

Regulatory affairs

CMC knowledge

Pharma industry

Education

Bachelor of Science in Health Sciences

Local registered pharmacist

Job description

The Position

The Specialist is responsible for all aspects of regulatory submissions in Philippines with minimal support. 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. This role reports to Country/Cluster Regulatory lead and may act as the regulatory relevant License Holder for the company.

Responsibilities

• Drive product registration plans and strategies and working cross-functionally to communicate and execute the registration strategy.
• 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

• Inspires growth: Identifies and analyzes business needs in terms of capabilities, skills, behaviors, and mindsets needed.
• Delivers with accountability: Monitors 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.
• Makes connections: Works in partnership with others (internally and externally) to accomplish quality goals.
• Communicates with optimism and authenticity: Demonstrates oral and written communications and presentation skills. Takes timely actions and determine when escalation of issues is necessary.
• Activates belonging: Reforms diverse representation and consideration in all talent selection and development activities across teams.

Required Education, Experience and Skills

• Minimum of 3 to 5 years of industry experience in regulatory affairs and/or CMC in MNC or Local market.
• 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.
• 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.

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 candi