In this challenging role in Regulatory Affairs, you will have oversight and accountability of deliverables of multiple senior Regulatory stakeholders (local markets and service providers, Global/External teams) and senior stakeholders from other functions (Commercial, Market Access, Medical Affairs, PV/Safety, R&D, Quality, Supply, Artwork). Leading a team of ambitious people who are passionate about having an impact, you will be given the best tools to succeed in this position. Lots of autonomy and flexibility! Role and responsibilities * Single Point of Accountability for all European Regulatory Affairs activities for the Sun Pharma Branded portfolio ( could be as with Australia and New Zealand oversight) * Accountable for regulatory development and registration strategies in line with Target Product Profile (TPP) and the business strategies and goals for new products. * Accountable for the quality of content, style and appropriateness of Scientific Advice briefing documents and... questions in line with the defined and agreed upon regulatory strategy. * Accountable for attainment of MAAs (or other) for all assigned products in line with TPP/business strategy and aligned company timelines. * Accountable for the submission and content of MAAs for assigned products. All risks to attainment of MAAs, alignment to TPP/business strategy, or project timelines to be escalated and mitigation plans developed. * Accountable for the maintenance of Regulatory compliance, and all associated European Regulatory Affairs activities, for the Branded portfolio in line with European Directive 2001/83/EC, 1234/2008/EC and regulation no. 726/2004, and associated guidelines. * Ensures all compliance deadlines (Internal or Health Authority driven) are met. * Ensures product artwork is developed in line with TPP and regulatory requirements, and is maintained and updated in compliance with regulatory requirements whilst ensuring continuity of supply is not impacted where avoidable. * Ensures resourcing needs are appropriately planned for upcoming workload/projects to achieve business goals, and raises requirements and/or risks to Head of Regulatory Affairs & Business Continuity Europe & ANZ, as needed. * Accountable for the engagement and alignment of local (whether internal or service provider) Regulatory inputs and outcomes for assigned products. * Accountable for oversight and delivery of technical and local regulatory service providers (non-budgetary) and due diligence of appropriate third-party experts. * Accountable for the delivery of any activities delegated to junior resources, where relevant. * Support Medical Affairs in ensuring Advertising and Educational Materials for assigned products meet the minimum European standards, and provide guidance and direction to Local Regulatory teams on responsibilities and specific country requirements (i.e. promotional certification, Fair Market Value for HCPs, etc.), where relevant. * Accountable as the named applicant and representative of Sun Pharma to Health Authorities for assigned products. * Accountable for optimising operating model and regulatory costs (submissions and personnel) associated with European Branded RA. * The scope of this position covers the development and registration strategy and delivery of pre- and post-authorisation regulatory activities for the Branded products portfolio in Europe. * Leads the European/ Australia/ New Zealand Regional regulatory strategy, regulatory authoring and submission of pre-authorisation (scientific advice, ODD, PIP, CTAs, appropriate clinical regulatory strategy, etc.), Marketing Authorization (MA) Applications and Lifecycle Management of existing MAs for the Branded products portfolio. * Conducts regulatory due diligence on business development assets in full alignment with the business team, under the supervision of Head of Regulatory Affairs & Business Continuity Europe & ANZ, as needed. * Provide leadership to the local RA teams with respect to implementation and maintenance of regulatory requirements across the region. Includes authoring/contribution to-/implementation of related SOPs as required, and alignment with the related SOPs. * Accountable for maintenance of Product Information (SmPC/Labelling/PIL) and summarized version for promotion, and coordination of national implementation in case of changes. Requirements * Bachelor’s Degree or equivalent in Pharmacy, Chemistry or life sciences. * Typically 10+ years’ experience in pharmaceutical Regulatory Affairs, ideally with at least 5 years in Branded and/or NCE RA. * Experience with Marketing Authorization (MA) Applications and Lifecycle Management of existing MAs for the Branded products portfolio. * English + any other European language Benefits * Competitive salary + nice package (meal vouchers, health insurance, etc) * Company car + fuel card * 3 days/week from home If this job appeals to you please apply here or send your CV to me, Bianca Lala, on the NonStop Recruitment website or on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network. NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover
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