Regulatory Affairs Manager

Are you an experienced Regulatory Affairs professional? Do you have a strong understanding of local regulations and a passion for ensuring compliance? We are looking for a Regulatory Affairs Manager to join our team in the Philippines affiliate. If you are ready to take on the challenge of managing regulatory operations and securing timely approvals for new drug and device applications, then read on and apply today for a life-changing career.

About the department
Novo Nordisk (NN) is a global healthcare company with more than 100 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders, rare diseases, and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs over 60,000 people globally and markets its products in more than 170 countries. In NN Philippines, the position provides the opportunity to work in a high performing team to contribute directly towards the business results while creating values for patients.

The position
As the Regulatory Affairs Manager for the Philippines affiliate, your role encompasses managing regulatory operations including the maintenance of PhFDA License to Operate for drugs and medical devices, overseeing the life-cycle management of product marketing authorizations, and securing timely approvals for new drug or device applications. You are also in charge of staying abreast of regulatory intelligence to ensure compliance with local regulations and providing regulatory support to different departments and teams within the affiliate, aligning with the local business demands. This position reports to the Associate Director for Medical & Regulatory, and this position is a single contributor role.

Other role expectations are:

• Preserve and maintain the affiliate’s license to operate for drug products and medical devices.
• Manage and supervise regulatory affairs (RA) applications for life-cycle management (LCM).
• Organize and supervise RA applications for new drug applications (NDAs) and medical device application.
• Develop affiliate-level regulatory strategy and implementation plans.
• Review and approve materials in Veeva PromoMats, initiate, review, proofread, and approve packaging materials.

Qualifications

• The ideal candidate should hold a university degree in either BS Industrial Pharmacy or BS Pharmacy and be a licensed Pharmacist with the Philippines Professional Regulation Commission.
• More than 10 years of related regulatory affairs experience required, with Advanced knowledge of pertinent local regulations.
• Attendance to PhFDA Academy trainings on: QPIRA, Licensing and Pharmacovigilance.
• Knowledge of diabetes, as well as of other therapeutic areas and/or biotech products relevant to Novo Nordisk are beneficial.
• Strong professional network within the pharmacists’ healthcare organizations and within the wider pharmaceutical industry associations.
• Experience with regulatory intelligence, advocacy and policy shaping is an advantage.
• Fluent in oral and written English.