Regulatory Pharmacist

Company Description

InnoGen Pharmaceuticals Inc. is a Philippine-based company focused on transforming existing pharmaceutical products into improved, high-quality, and cost-effective drug formulations for end-users. Formed through the merger of nine Filipino-owned pharmaceutical companies in 2010, InnoGen now concentrates on Cardio-Metabolic, CNS and Gastro, and Anti-infective and Respiratory therapeutic areas, with ethical marketing and national coverage. The company is recognized as the first national firm to provide second to innovator off-patent molecules, expanding access to essential treatments. Through technology transfer and global partnerships, InnoGen gains access to advanced pharmaceutical information and facilities. Guided by its vision to lead the Philippine market and compete globally, the company is driven by the values of health, integrity, customer focus, commitment, unity, respect, entrepreneurial excellence, and practicality under the guiding phrase Innovating Generics and the battle cry We Value Life.

Role Description

The Regulatory Pharmacist is a full-time, on-site role based in Quezon City, responsible for ensuring compliance of pharmaceutical products and processes with national and international regulatory requirements. This role involves preparing, reviewing, and submitting regulatory documents and dossiers to health authorities, tracking application statuses, and maintaining accurate regulatory records. The Regulatory Pharmacist collaborates with cross-functional teams, including R&D, quality assurance, manufacturing, and marketing, to support product registration, variations, renewals, and post-marketing compliance. Daily tasks include monitoring regulatory updates, interpreting guidelines, advising internal stakeholders on regulatory impacts, and supporting audits and inspections. The role also contributes to continuous improvement of regulatory processes and helps ensure that InnoGen's innovative generic products meet quality, safety, and efficacy standards.

Qualifications

• With minimal foundation in regulatory affairs for pharmaceuticals, including knowledge of local and international drug registration, licensing, and post-marketing requirements.
• Solid background in pharmacy and pharmacology, with the ability to understand formulations, therapeutic indications, safety profiles, and manufacturing processes.
• Competence in documentation and technical writing, including preparation of dossiers, standard operating procedures, reports, and responses to regulatory queries.
• Analytical and research skills to interpret regulatory guidelines, assess risks, and provide clear recommendations to internal teams.
• Effective communication and collaboration skills for working with cross-functional teams and engaging with regulatory agencies in a professional manner.
• Bachelor's degree in Pharmacy and valid pharmacist license in the Philippines.
• Previous experience in regulatory affairs, quality assurance, or related pharmaceutical roles is highly advantageous.
• Detail-oriented, organized, and able to manage multiple submissions and timelines in a fast-paced environment.
• Commitment to ethical practices, continuous learning, and alignment with InnoGen's mission to provide quality, innovative
• Willing to work on site