Regulatory Affairs & Pharmacovigilance Manager, ASKAN

THE POSITION

This position is responsible for managing the end-to-end product registration process, ensuring compliance with local regulatory authorities and Global Regulatory Affairs (GRA), maintaining product licenses, and supporting life cycle management (LCM) activities. It also oversees the Regional Operating Unit (ROPU) Pharmacovigilance (PV) system in alignment with local regulations and global PV requirements.

The role serves as a key link between GRA and Regulatory Affairs (RA) functions across ROPU ASKAN countries, providing support in the execution and coordination of RA activities within the region.

In addition, the position acts as Deputy Local Pharmacovigilance Officer (Deputy LPVO), supporting pharmacovigilance reporting and ensuring effective coordination between Global PV and ROPU ASKAN countries in compliance with both local and global standards. In close collaboration with the LPVO, the role serves as a primary point of contact for country RA managers across ROPU ASKAN countries

Tasks & responsibilities

• Responsible for the management of product registration activities, in accordance with corporate policies and strategic direction of GRA and according to the particularities and legislation required by ROPU ASKAN countries


• Responsible for maintaining and updating the GRA databases and associated systems (e.g., DAVID, BIRDS, PV Express II, PV Works, Product Readiness, OnePAC).


• Manage the activities of RA in order to obtain and maintain licenses, renewal and changes in product registrations; action plan with ROPU ASKAN countries and GRA as well as monitoring the implementation of ROPU ASKAN RA strategy.


• Responsibility for the management of Life Cycle Management (LCM) activities in compliance with the existing legislation and policies, facilitating the regulatory needs and RA priorities of ROPU ASKAN countries in cooperating with Global Strategic Marketing and Global Innovation teams;


• Management of information and regulatory dossiers in order to ensure confidentiality, information protection and agility to provide information.


• To identify and to anticipate developments and changes in the regulatory affairs policies or in agencies organization (Regulatory Intelligence).


• Organize and update status  for the registration processes in ROPU ASKAN.


• Initiate and drive communication with the ROPU ASKAN RA colleagues.


• Training of RA colleagues to ensure high quality output.


• Assist LPVO at ROPU ASKAN monitors and improves ROPU PV data collection and reporting system as well as PV trainings (incl. documentation of training of third party according to contract).


• Ensures correctness, completeness and reliability of PV information.


• Act as contact for Global PV and local RA. Supports production and submission of aggregated AERs. Notifies Global PV of any PV related concerns identified by the OPU (PV Signals) or expressed by the national authority (e.g., changes of SPC/package insert).


• Informs Global PV on any actions taken for safety reasons. Exchanges PV information of co-marketed and in-licensed products according to PV agreement (‘Safety data exchange agreement’).


• Provides AER in humans and drug exposure during pregnancy for products of the shared active ingredient list immediately to L-PV HP.

Requirements

• Doctor of Veterinary Medicine or Pharmacy or Life Science degree


• At least 5 years of Regulatory Affairs experience within the pharmaceutical industry, either in human or animal health sectors


• Experience in the biopharmaceutical industry, covering human or animal health, is preferred.


• Experience working in culturally diverse teams


• Demonstrates initiative and a growth mindset.


• Planning skills; detail orientation


• Business acumen and project management skills


• Strong accountability and results oriented


• Leadership and communication skills


• Fluency in both written and spoken English