Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager (DACH/NORDIC)Job Type: Full Time, Fixed Term Contract – 10 to 12 Months (Maternity Cover)Location: Copenhagen, Denmark or Stockholm, Sweden (Hybrid 3x a week on site)Remuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specialises in Cancer and Supportive Care, Gastroenterology and Hepatology. The business is looking for someone to join the team on a fixed term basis.The person holding this position will report to the Associate Director and be a member of the Regulatory Affairs team.The core responsibility of the of Regulatory Affairs Manager is to contribute to the growth and expansion the business through partnership with local teams within the Rx and Consumer Health Business Units and global development teams. They will also be responsible for the co-ordination, planning and interfacing with centrally driven development, lifecycle and labelling activities and through ensuring integration and launch of new assets in the Nordics and for strategic and operational oversight of all regulatory activities associated with the Nordics within the DACH and Nordics cluster and all regulatory development activities associated with those projects under his/her responsibility.This will be a 12-month fixed-term contract role.To be responsible for all product launches, new formulations, integrations for countries in scopeTo liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to proactively communicate with regulatory authorities in order to expedite approval of submissionsTo partner with local stakeholders to ensure co-ordination of approach across products and central strategic positions for country utilisationTo be the regulatory subject matter expert in area country responsibilityTo manage and lead projects under his/her responsibilityTo represent Regulatory Affairs in the RCU leadership teamTo provide regulatory oversight for country specific submissionsTo support local Pricing & Reimbursement activitiesTo provide expert regulatory input for acquisition of products pre-launch & -approvalTo provide advice and recommendations on regulatory strategiesTo provide Regulatory Intelligence, in-country and regional (EMA)To provide regulatory support when preparing for and during GxP inspections for countries in scopeTo contribute to oversight of regulatory submissions for DACH & NordicsTo anticipate and resolve complex regulatory issues independentlyTo have budgetary responsibility and oversight for countries in scopeTo provide information on expenditure against budget for inclusion in periodic financial reportsWhere Regulatory input is required by local law or codes; ensuring promotional compliance with legislation and relevant internal/external codes within the relevant RRUsRequirements: Good degree in a relevant life science subject or equivalentMUST Speak a NORDIC languageBroad regulatory experience, part of which should have been gained operating at a senior level and general knowledge of worldwide regulatory requirements (including GMP).A full strategic understanding of the drug development and life-cycle management principles and processesDemonstrates subject matter expertise, e.g. expertise in projects/therapy area/CMC/labelling, or country knowledgeAbility to communicate clearly in EnglishAwareness, understanding and an ability to interpret the ICH guidelines relevant to their technical/functional responsibilities, specifically for the technical/functional responsibilities related to delivering a TPP at the end of the development processFor more information, please reach out to me at lucy.kirkaldy@cpl.com