Haleon is seeking a Regional Regulatory Strategist to join the team. The Regional Regulatory Strategist provides strategic regulatory expertise for regional projects involving multiple Business Units (BUs) within the region. They are responsible for developing and implementing creative regulatory strategies for innovation involving multiple EU markets where central coordination is required. In this role the individual will build a network of collaborative relationships within the EMEA & LATAM R&D organization, R&D and Commercial teams in the BUs, LOC and Global RA, and Global Safety & Medical to ensure delivery of agreed innovation, timely submissions and approvals for central registration, certification or notification procedures, as well as product stewardship activities associated with existing business in the region. The Regional Regulatory Strategist also has a key role in external engagement and influencing the regulatory environment in the region via involvement in pan-European Industry Associations. They will partner with EU Corporate Affairs to keep EU BUs and Global Regulatory Intelligence and Policy team informed of emerging issues, new proposed EU guidance or legislation that could impact Haleon’s CH business.
- Minimum Qualification:Degree
- Experience Level:Mid level
- Experience Length:5 years
- Accountable for development and implementation of effective Regional Regulatory Strategies for regional innovation projects involving multiple EU markets across Business Units. This may include geo-expansion of existing products to other markets/BUs within the region.
- Accountable for regulatory evaluation of external product opportunities for the region that could be of interest to multiple EU markets/BUs, in collaboration with Business Development, Regional R&D and LOCs - providing detailed Regulatory feasibility assessments and risk analyses to enable technical risk assessment and informed decision-making by EMEA R&D and Commercial Leadership.
- Leading development/coordination of high quality regulatory dossiers/data packages for regional submissions to external regulatory agencies, in close cooperation with Global RA/CMC, GSM, and Regional Commercial and R&D.
- Development of core labelling associated with new product innovation.
- Accountable for product stewardship activities for an assigned group of products for one or more therapeutic areas or regulatory classifications requiring central coordination, e.g., EU CP/DCP/MRP Licences, Medical Device Technical Files, Cosmetics PIFs and core labelling updates. For medicinal products, this includes leading internal regulatory response teams, ensuring approvals are obtained in a timely manner, and ensuring optimal Regulatory Agency interactions.
- Leading pivotal maintenance or business continuity projects affecting multiple markets within the region.
- Ensuring compliance with global, regional and local processes, policies, SOPs and working instructions.
- Proactively influencing the regulatory environment based on technical regulatory knowledge and experience - may act as a Haleon representative on external industry association committees, key task forces or working groups within key pan-European Industry Associations (e.g. AESGP, Cosmetics Europe, Food Supplements Europe) to drive the company’s agenda and provide creative solutions to Regulatory challenges and issues.
- Responsible for keeping the BUs informed of emerging issues, and new proposed EU guidance or legislation that could impact the business
- Partnering with EU Corporate Affairs and Global Regulatory Intelligence and Policy team to align on external positions and strategies for issue management for pan-EU-specific issues.
Qualifications And Skills:
- BSc Degree in a pharmaceutical or life science or equivalent
- 5 years+ Regulatory experience in a Consumer Health/OTC environment
- Demonstrated knowledge of EU regulatory procedures and requirements for medicines and ideally medical devices, cosmetics or food supplements
- Direct experience of managing national and/or regional registration or notification processes
- Direct experience of communicating with external regulatory agencies, assessing Health Authority requests/questions and leading preparation of cross-functional responses
- Experience of working flexibly across a portfolio of products, handling multiple project priorities
- Proven ability to communicate complex information to a variety of audiences in both verbal and written format, including Commercial and Senior management
- Demonstrated Commercial awareness and ability to act as a strategic business partner
- Evidence of creative and strategic thinking, analytical and problem-solving skills, and technical writing skills
- Strong Knowledge of EU Regulatory medical products (MRP/DCP and CP)
- Strategic thinking and ability to understand and communicate complex situations from a regulatory point of view
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