Regulatory affairs manager

OverviewThe Regulatory Affairs Manager is responsible for leading, developing, and managing a high-performing Regulatory Affairs team supporting global product portfolios. This includes setting clear objectives, driving accountability, and fostering a collaborative, performance-driven culture to ensure consistent delivery of high-quality regulatory outcomes.ResponsibilitiesLeading, directing, and ensuring accountability of the team for the management and sustained performance of the Irish Regulatory Affairs team responsible for global products (MAs granted via Centralised, MRP/DCP/RUP, and Irish National procedures).Coaching, mentoring, and developing team members for the continuous development of direct reports to ensure capabilities in line with regional and local functional needs, sustained team engagement, and execution of succession planning.Aligning team priorities and driving execution for business-aligned regulatory filing and new product launch strategies in collaboration with regional and local stakeholders.Ensuring team delivery and adherence to timelines for the timely filing of post-authorisation regulatory submissions such as variations, Article 61(3) applications, renewals, PSURs, DSURs, risk minimisation measures, Sunset Clause notifications, safety label updates and post approval commitments.Guiding team expertise and decision-making in the assessment of CMC regulatory data requirements and development of regulatory submission strategies considering both compliance and commercial needs.Acting as regulatory lead in collaboration and business partnering to ensure awareness of external customer needs, responsibilities, and priorities, and effective execution of cross-functional working.Overseeing and coordinating team responses in engagement with the HPRA to address application queries, liaising with relevant company departments and external sources to ensure full and rapid responses.Driving performance excellence across the team through oversight and reporting of department KPIs, with accurate maintenance of regulatory databases and systems.Ensuring team awareness and capability development through timely gap assessment of internal operating procedures and external regulatory intelligence, including updates to local procedures and communication to affected stakeholders.Preparing and leading the team for inspections and audits, acting as a regulatory subject matter expert as required in internal audits and Health Authority inspections.Ensuring team compliance and quality execution in coordination and execution of regulatory activities within Sandoz Quality Management Systems, including change control, deviations, quality events, CAPAs and operating procedure maintenance.Providing leadership input and budget oversight, including contribution to budget development, and ensuring team adherence to department spending plans and financial controls.Essential RequirementsWhat you’ll bring to the role:BSc (Hons) Chemistry or Life Sciences (upper second class or higher) required; MPharm (Pharmacy) highly desirable.Proven people management experience, with a strong track record of leading, mentoring, and developing high-performing teams, including driving engagement, performance management, and succession planning.Excellent current regulatory knowledge of Centralised, MRP/DCP/RUP, and Irish National licensing procedures.Excellent knowledge of regulatory lifecycle maintenance requirements.Proven track record of working with the HPRA.Strong analytical approach balanced with a keen eye for detail, demonstrated across document control and regulatory deliverables; high degree of computer literacy in scientific and role-related systems.Strong leadership and communication skills, with demonstrated ability to recruit, coach, motivate, and develop staff to achieve both organisational objectives and individual career growth.Proven track record in the delivery of complex regulatory, technical, and scientific projects, including leading cross-functional teams to successful outcomes.Strategic and entrepreneurial thinker, capable of setting direction and inspiring teams to deliver results against tight timelines and evolving business priorities.Experience with internal and external inspections, including leading teams through inspection readiness and execution.Excellent communication skills, with ability to influence senior stakeholders and foster effective collaboration across teams.You’ll ReceiveCompetitive salary, Annual bonus, Pension scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.Why Sandoz?Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries. While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported.Join us, help us make healthcare fairer and faster.Commitment To Diversity & InclusionWe are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.#Sandoz
#J-18808-Ljbffr