Regulatory Affairs Product Lead – Stockholm – 8 month contract
Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Regulatory Affairs Product Lead to work with a Global pharmaceutical company based in Stockholm.
Based in Stockholm this role includes operational regulatory affairs activities, involving interface from LOC to European and Global RA, ensuring conformance to national and EU Drug Laws, maintaining labelling information to internal and external partners, communicating with national regulatory authority and regulatory institutions if required in collaboration with EU strategists, supporting internal Global RA, other R&D departments and providing collaborative support for commercial teams.
- Acts as country RA Product Lead with primary national regulatory responsibilities for Sweden and Iceland for assigned product franchise(s), and serves as regular back-up for other RA Product Lead in Sweden, and for other country RA Nordics Baltics when applicable.
- Submit applications to national authorities in Sweden and Iceland for products approved in the national procedure, and for the national phase for products approved through MRP and DCP, where applicable
- Ensure in conjunction with the Nordic-Baltic Regulatory Lead and country RA Product Leads that regulatory requirements of the Nordic & Baltic region are fully represented in discussions at Global, Regional and Local levels.
- Provide local support to the EU Regulatory strategists for local submission when necessary in case of specific contact to take with the agency or review of national requirements.
- Submission of PASS protocols to the national regulatory authorities.
- Provide regulatory input to Health technology appraisal/ horizon scanning for product portfolio, when applicable.
- Provide regulatory guidance and support of Early Access of Medicines (Named patient use, compassionate use etc.)
- Review of promotional materials and patient support materials on products according to Swedish national advertising law and applicable codes of practice and in line with SOP, WI and LIP
- Responsible for providing the consolidated feedback regarding the text translation (in Swedish) from the relevant functions in the affiliate to the EU Regulatory Strategists/Global Labelling team.
- Management of artworks – centralized, MRP/DCP and national products: review and approve artworks.
- Provide advice to LOC team, International Commercial, on maintaining compliance of activities and materials with local regulations/requirements codes at any International symposia/conferences to be held in Sweden
- Responsible for bringing to the attention of R&D Compliance/Quality Assurance any planned local SOP or local SOP revision, which they are aware of, and which relates to R&D activities
- Responsible for immediately notifying R&D Compliance/Quality Assurance of any planned health authority inspection relating to R&D activities and will work with R&D Compliance/Quality Assurance to prepare for the inspection, receive/host the inspection, and respond to findings
Education and experience
- BSc/MSc in a scientific discipline.
- Minimum 8 years of experience with multinational companies in regulatory affairs.
- Proven experience and relationship with Nordics Regulatory Authorities
- Strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies.
- Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business.
- Effectively embraces change and is able to flourish in a global structure, aligning people and processes to deliver excellence.
- Creates an open collaborative environment of continuous improvement within LOC stakeholders and Global functions
- Demonstrated ability to assess the internal and external environment to recommend appropriate risk- taking.