[Hiring] Regulatory Affairs Specialist @Organon

Role Description

The Specialist is responsible for all aspects of regulatory submissions in the 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 to meet local legislations and company procedures. This role reports to the Country/Cluster Regulatory lead and may act as the regulatory relevant License Holder for the company.

• Drive product registration plans and strategies and work cross-functionally to communicate and execute the registration strategy.
• Timely preparation and submission of new Marketing Authorization Applications to local Health Authorities.
• Maintenance of authorized products through timely submission of post-market regulatory dossiers including variations, renewal applications, and supplemental marketing authorization.
• Archiving and maintenance of regulatory data and documentation in accordance with department and company policies.
• Ensure compliance with global and local SOPs and report any deviations or compliance concerns immediately.
• Support local audits, inspections, and readiness activities including audits of contractual partners/vendors.
• Assist in developing local procedures for the department and evaluate processes for potential improvement.
• Proactively identify procedural gaps and challenges and implement solutions in collaboration with stakeholders.
• May be assigned to support drug shortage management and regulatory requirements for reporting.
• Ensure awareness on obligations to comply with regulatory requirements and decisions made by top management.

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 expertise in local regulatory processes.
• University Degree, B.Sc. or higher in Health Sciences (including chemistry, biochemistry, physiology) or equivalent.

Requirements

• Identifies and analyzes business needs in terms of capabilities, skills, behaviors, and mindsets needed.
• Monitors regulatory trends, drives compliance, and proactively manages and mitigates risks.
• Encourages diverse thinking and experiments with new ways of working.
• Works in partnership with others (internally and externally) to accomplish quality goals.
• Demonstrates oral and written communications and presentation skills.
• Reinforces diverse representation and consideration in all talent selection and development activities.

Benefits

• Remote work flexibility.
• Regular employee status.
• No relocation assistance.
• No visa sponsorship.
• Travel requirements: Organon employees must satisfy all applicable travel and credentialing requirements.