Specialist, Regulatory Affairs

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

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.

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.

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

Reinforces 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 candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)