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Director, Regulatory Affairs Consulting & RIM Strategy

  • Remote
  • Sweden
  • English
  • Posted 23.09.26 16:19

Director, Regulatory Affairs Consulting & RIM StrategyLocation: Remote - Eastern EuropeIndustry: Life Sciences ConsultingEmployment Type: Contract - 9 months with a view to extendHours: Full-time The OpportunityWe are partnering with a leading global Life Sciences consulting organization to recruit a senior Regulatory Affairs leader with expertise in Regulatory Information Management (RIM), Regulatory Operations, and Regulatory Strategy.This is a high-impact leadership role responsible for advising pharmaceutical and biotechnology clients on complex regulatory initiatives, driving business growth, and leading the delivery of large-scale transformation programmes. The successful candidate will work closely with senior client stakeholders, shape strategic solutions, and play a key role in expanding the organization's Regulatory Affairs consulting practice. Key ResponsibilitiesClient Advisory & ConsultingLead Regulatory Affairs consulting engagements across Regulatory Strategy, Regulatory Operations, Submission Management, M&A integrations, and RIM transformation initiatives.Act as a trusted advisor to senior regulatory stakeholders across pharmaceutical, biotech, and life sciences organizations.Design and deliver tailored solutions to address clients' regulatory and operational challenges.Lead governance meetings, executive presentations, and strategic client discussions. Regulatory Information Management (RIM) LeadershipOwn and drive RIM strategy, governance, operating models, and transformation programmes.Lead RIM remediation, optimisation, implementation, and data quality initiatives.Ensure regulatory systems, processes, and data support compliance and inspection readiness requirements.Partner with clients to deliver scalable digital solutions aligned with regulatory business needs. Business Growth & DevelopmentSupport the development of new business opportunities and strategic client relationships.Contribute to RFP responses, solution design, and proposal development.Present at client meetings, industry events, and conferences.Build and maintain relationships with senior Regulatory Affairs leaders across the industry. Leadership & DeliveryLead global, cross-functional teams delivering complex regulatory programmes.Ensure projects are delivered on time, within budget, and to the highest quality standards.Provide mentorship and leadership to consulting teams, project managers, and regulatory specialists.Drive operational excellence, risk management, and programme governance across engagements. Required ExperienceBachelor's degree in a scientific, engineering, or related discipline.10+ years of Regulatory Affairs experience within the pharmaceutical, biotechnology, CRO, or consulting sector.Strong experience across Regulatory Strategy, Regulatory Operations, or Regulatory Information Management (RIM).Demonstrated success leading large-scale regulatory transformation or operational improvement programmes.Excellent stakeholder management skills with experience engaging senior and executive-level audiences.Proven programme and project leadership experience. Preferred ExperienceRegulatory Information Management (RIM) system implementation or optimisation experience.Experience leading regulatory submissions for global pharmaceutical organisations.Management consulting or advisory services experience.Experience overseeing multi-country or global regulatory programmes.Knowledge of regulatory requirements across multiple regions. Key CompetenciesStrategic thinker with strong commercial awareness.Excellent communication and presentation skills.Executive presence and ability to influence senior stakeholders.Strong leadership, coaching, and people management capabilities.Highly organised with exceptional problem-solving and decision-making skills.Able to thrive in a fast-paced, client-focused environment. Why Apply?Opportunity to lead high-profile regulatory transformation programmes.Exposure to top-tier pharmaceutical and biotechnology clients.Significant scope for leadership, business development, and career progression.Chance to shape the future of Regulatory Affairs and RIM consulting within a growing practice.