Head of Regulatory Affairs

Job description

In this position you will provide strategy, guidance and leadership to the local Regulatory Affairs (RA) team. You will ensure the timely submission of applications and regulatory compliance of the Operating Unit (OPU)'s portfolio with local regulatory requirements in order to sustain a continuous market supply and patient safety. You will provide excellent expertise and knowledge of the regulatory environment as well as contacts to local Health Authorities to support Boehringer Ingelheim's businesses in the OPU. Therefore a correct allocation of the resources is required.

Job Profile

· Ensures a timely submission and successful registration of new products in line with local requirements
· Develops and aligns the local registration strategy within medicine (Med) and the local business
· Aligns the strategy with the Regional Operating Unit (ROPU) and global strategy
· Maintains the existing national Marketing Authorizations in line with local requirements and global standards
· Ensures a regulatory assessment of New Business Opportunity (NBO) local implementation and enforces the local NBO execution
· Keeps the Local Medical Director, ROPU & Regional Head of RA and local business partners informed of new regulations or updates, and ensures a high qualified regulatory impact assessment in a timely manner
· Establishes, develops and maintains close relationships with relevant National Regulatory Authorities and other bodies, organizations and key stakeholders in order to facilitate and develop effective collaboration on all regulatory interactions and promote the interests of the company
· Ensures that products' promotion in the market is in compliance with the local and global regulatory framework, in order to sustain and expand the business
· Participates in the Promotional Material Approval process in order to ensure regulatory compliance regarding these promotional materials and activities
· Ensures compliance and quality of the local RA organization by ensuring a proper Quality System, supports local inspection readiness and contributes to the CAPA process as appropriate
· Develops talent management and -development in the Operating Unit with cross-functional collaboration
· Acts as Qualified Person as requested per the local regulation
· Manages regulatory submissions in order to support clinical trial activities in the OPU
· Collaborates with Market Access in the interactions with the national authorities/bodies
· Ensures non-international products (NIPS) process implementation and execution
· Ensures timely provision of CPPs (Certificates of a Pharmaceutical Product) to support regulatory processes in other countries

Requirements

· Master's degree in Pharmacy or Medicine; or equivalent life sciences, engineering or related technical field
· 3-5 years' experience in Regulatory Affairs in the pharmaceutical industry
· Experience in Clinical Operations or a Pharmacy will be considered
· Fluency in Norwegian and an excellent command of the English language
· Leadership experience an asset
· Strong organisational and communication skills
· Proactive and assertive attitude
· Team- and networker
· Able to plan and prioritize If you have any questions related to the recruitment process, please do not hesitate to contact Talent Acquisition MIDI: ************@*******.**