Regulatory Submissions & Lifecycle Specialist — Philippines

Organon; Manila; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

Organon Philippines is seeking a Regulatory Specialist responsible for all regulatory submissions with minimal support. You will work to ensure products meet local legislations and company procedures, manage post-marketing lifecycle activities, and monitor regulatory surveillance in collaboration with cross-functional teams.

Reporting to the Country/Cluster Regulatory lead, you will ensure compliance with local regulations, support supply continuity, and may act as regulatory license holder for

Qualifications

• 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.
• Sound knowledge of regulations within the assigned markets and be an expert in local regulatory processes and activities.

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.

Skills

Regulatory affairs

CMC experience

Pharmacist licensed

Cross-functional collaboration

Education

Bachelor of Science in Health Sciences

Local pharmacist license

Job description

Organon Philippines is seeking a Regulatory Specialist responsible for all regulatory submissions with minimal support. You will work to ensure products meet local legislations and company procedures, manage post-marketing lifecycle activities, and monitor regulatory surveillance in collaboration with cross-functional teams.

Reporting to the Country/Cluster Regulatory lead, you will ensure compliance with local regulations, support supply continuity, and may act as regulatory license holder for