Regulatory Affairs Specialist

The Company 

iNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today. 

The Opportunity 

We are seeking a dynamic and detail-oriented regulatory affairs professional to support the growth of our business in the Philippines by delivering actionable regulatory and compliance support. This role is responsible for the registration and maintenance of product registrations and company licenses, ensuring full compliance with local regulations and global quality standards.

In addition, the role serves as the local Pharmacovigilance (PV) support for iNova Philippines, working closely with the Global Patient Safety and Risk Management (GPRM) team to monitor, detect, assess, and report adverse events and adverse drug reactions in accordance with company SOPs and local regulatory requirements.

The successful candidate will collaborate cross-functionally with internal stakeholders to support key business objectives, contribute to regulatory excellence, and help ensure the safe, compliant, and uninterrupted supply of iNova products to patients and consumers across the Philippines.

Key Accountabilities & Performance Indicators

A. Regulatory Affairs

• Support the achievement of company goals through the registration and maintenance of product registrations and company licenses with regulatory agencies (e.g. Philippine FDA, PDEA, DOH).
• Apply for the necessary permits/licenses for the release of products from source to designated warehouse and for the implementation of marketing-initiated activities.
• Provide technical assistance to relevant departments on regulatory matters, including inclusion of products in the formulary and educating customers on regulatory guidelines.
• Coordinate with relevant departments on compliance with regulatory requirements such as the development and implementation of approved artworks and labelling.
• Provide necessary documents to third-party service providers for the maintenance of products in their systems/databases.
• Support the establishment and maintenance of Standard Operating Procedures (SOPs) and systems required for the maintenance of product registrations and company licenses.
• Regularly update regulatory databases/monitoring records and provide periodic updates to the Regulatory Affairs Manager and Regional RA Lead.
• Establish and maintain relationships with applicable regulatory agencies and pharmaceutical associations to stay current with local and international guidelines.
  

B. Pharmacovigilance (PV)

• Act as the local PV contact for iNova Philippines, working closely with the Global Patient Safety and Risk Management (GPRM) team on all safety surveillance activities.
• Receive, record and report all adverse events/adverse drug reactions (serious and non-serious) for iNova products within the required regulatory timelines, in accordance with company SOPs and local law.
• Monitor, detect and evaluate drug safety hazards, and support the overall local safety assessment, evaluation and risk management of products or product groups.
• Support the reconciliation of adverse events with other functions (e.g. Medical Information, complaints, market research and patient support programs).
• Communicate and manage local PV vendors and agencies where applicable, and support local safety-related regulatory submissions.
• Ensure PV-related SOPs and training records are current, and that adverse event awareness is maintained across the local organization.
• Participate as a member in regular meetings with the GPRM team and provide periodic PV reports/updates.

C. Quality & Compliance

• Participate in local and regional meetings/trainings and ensure competence in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Storage Practice (GSP), Good Regulatory Practice (GRP) and Good Pharmacovigilance Practice (GVP).
• Observe at all times the iNova Promotional Practices Policy, Anti-Corruption Policy, Code of Business Conduct and the Employee Manual.
• Comply with the PHAP Code of Practice and all applicable Philippine laws and regulations.
• Perform other job-related tasks as directed by superiors and other key officers of the company.

Key Performance Indicators

• Up-to-date product registrations and company licenses.
• Timely availability of required permits/licenses.
• Timely and compliant reporting of adverse events/adverse drug reactions within regulatory timelines.
• Up-to-date SOPs (RA and PV) aligned with current practice and regulations.
• Attendance at applicable meetings/trainings and proper implementation of GxP and GVP principles.
• Timely submission of RA and PV reports and regulatory updates.
• Consistent observance of company rules, industry codes of conduct and applicable Philippine laws/regulations.

About You 

To be successful in this role, you will possess the following qualifications and attributes:

• Licensed Pharmacist; Bachelor’s degree in Pharmacy 
• Post-graduate degree in science is desirable.
• At least two (2) years of experience in the pharmaceutical industry or in FMCG industry
• Knowledge of the regulatory environment in the Philippines, including labelling regulations and controls.
• Working knowledge of pharmacovigilance principles and adverse event reporting requirements is an advantage.
  
• Flexible and capable of prioritizing projects, meeting deadlines and working well under pressure.
• Strong project management and organizational skills; excellent oral and written communication skills.
• High attention to detail and accuracy.
• Demonstrated interpersonal and communication skills; technical writing capability preferred.
• Customer-focused, results-oriented, analytical and a good planner.
• Able to interact with internal and external stakeholders in a professional manner.
• Able to work independently and actively participate as a team member.