Rxilient offers full value chain capabilities, from registration and commercialization to manufacturing and supply chain management. Partnering with innovators and multinationals to develop and commercialize leading medicines.
The Role
Primary Duties And Responsibilities
- This role is responsible for leading and managing the Regulatory Affairs activities in Philippines to ensure that all pharmaceutical products and medical devices comply with applicable regulations. By reporting directly to Regional Regulatory Affairs Director, this role involves handling regulatory submissions, managing professional relationships with regulatory agencies such as the Food and Drug Administration (FDA) Philippines and trade associations, and ensuring that the company adheres to all local and international laws, regulations, and standards.
- Review, compile, and submit NDAs for Pharmaceutical products and medical devices to local regulatory authorities, following local regulations and international formats such as ICH and ACTD.
- Develop and execute local regulatory strategies for changes to existing pharmaceutical products and medical devices. Ensure regulatory compliance and support license renewals, safety reports, for the existing product portfolio, aligning with business needs.
- Manage the compilation and submission of responses to queries raised during evaluations, coordinating with internal functions and ensuring timely approval.
- Work closely with internal functions such as production, commercial, supply chain, QA and PV to address regulatory compliance for new product launches, including compliance of product labels, promotional material reviews, alignment with brand guidelines and registered product details and commercial shipments within Philippines.
- Stay up to date with regulation updates in the local market and access their impacts on the organization.
- Perform any other ad-hoc duties as and when assigned by the Company.
Ideal Profile
Job Specification
- Must be a licensed pharmacist in the Philippines.
- Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degree preferred.
- Minimum of 7-10 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of local drug and medical device regulatory processes and regulations, ICH guidelines, and international regulatory standards.
- Proven track record of successful product registration and interactions with regulatory agencies experience.
- Strong understanding of drug and medical device regulatory processes and requirements.
- Excellent project management skills with the ability to coordinate multiple stakeholders.
- Strong interpersonal and communication skills to collaborate effectively with internal and external stakeholders.
- Attention to detail and ability to work in a highly regulated and compliance-driven environment.
- Proficient in using regulatory systems and databases.
- Familiarity with safety updates reporting and market intelligence activities.
- Ability to stay updated with regulatory changes and adapt strategies accordingly.
- Fluent in English (written and verbal).
- Regulatory affairs certifications or professional memberships are desirable.
What's on Offer
- Attractive Salary & Benefits
- Fantastic work culture
- Strong opportunities to progress your career
