Specialist, Regulatory Affairs

Organon; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Organon is seeking a Regulatory Specialist to manage submissions and lifecycle activities for the Philippines market, collaborating with cross-functional teams to ensure compliance with local regulations and global standards.

The role involves preparing MAAs, variations, renewals, and labeling support, while maintaining regulatory data and supporting audits and CAPA processes. A licensed pharmacist with 3–5 years of regulatory experience is required.

Qualifications

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

Responsibilities

• Drive product registration plans and cross-functional communication to execute strategy.
• Prepare and submit MAAs and post-market regulatory dossiers per local regulations.
• Archive regulatory data per policies and local requirements.
• Ensure SOP compliance and drive CAPAs for non-conformities locally.
• Support local audits, inspections, and readiness activities.
• Develop local procedures to improve efficiency and processes.
• Identify procedural gaps and implement solutions with stakeholders.
• Support drug shortage management and regulatory reporting with Quality and Supply Chain.

Skills

Regulatory affairs

CMC

Licensed pharmacist

Education

Bachelor’s degree in Health Sciences

Licensed pharmacist

Job description

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.

Search Firm Representatives Please Read Carefully

Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

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

10%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1