Regulatory Affairs Manager at GlaxoSmithKline

Requisition ID: WD80623
Functional area: Regulatory

Key Responsibilities

• Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market
• Analyze regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and plans to mitigate, so that we can deliver products backed by science that are robust and aligned with business needs
• Actively contribute to high performing teams, including looking for ways to improve performance. May lead direct reports or cross-functional teams within local market
• Build relationships with key stakeholders and represent GSK in a responsible manner according to company values, in order to communicate GSK CH policies and strategies and negotiate outcomes
• Manage compliance within defined portfolio/activity streams in line with GSK CH expectations -  support key processes and ways of working (eg, in relation to GSK CMC, quality, product labeling requirements as well as local MoH regulations). Propose solutions to identified issues and implement
• Collaborative working together with other functions (eg, marketing, supply chain) to deliver agreed NPD and value engineering projects
• Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated
• Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business                                                                                                           
• Maintain required regulatory compliance databases, systems and processes. Train other company stakeholders as required to build knowledge and compliant utilization
• Maintain high level of knowledge on the science of products within defined portfolio

Application of Knowledge:

• The role is accountable for the preparation and delivery of regulatory activities and outcomes across a range of areas, including sign off and execution of all regulatory interfaces in the market.  This includes Ministries of Health (filings and meetings), Trade Associations, Advertising review bodies etc..  All product classifications are in scope, whether known (drugs, cosmetics, devices, foods) or potentially new (e.g. digital apps, biocides, botanicals, biologics).
• The position reports to the local regulatory lead ( or potentially to an area lead ), and is also accountable to support local commercial teams as a partner to deliver projects and strategies. The role may also lead locally based regulatory staff.
• The role needs to be keep up to date with relevant science and regulations within defined portfolio in order to effectively deliver  NPD and support base business.

Interaction:

• Needs to be able to work effectively across all dimensions of matrix organization (effective written and verbal communication is critical to success here). Senior management interactions within local market and externally
• Multiple internal interfaces with commercial, quality, medical, supply chain, legal, government affairs, communications within local market and globally within relevant technical/category streams
• Ministries of Health (technical and regulatory discussion of products and local regulatory processes)
• Trade Associations (represent GSK and participate in relevant work groups, eg. advertising, branding, ingredient defense, new and emerging regulation): The position requires ability to communicate clearly and effectively through a wide range of levels in the external environment
• May be a member of (or lead) local project teams, cross-functional teams and other local/international work groups.
• May be a member of local quality teams to ensure appropriate compliance activities are in place, including alignment of regional and global R&D risk management plans with local practices and escalation of regional issues.

Problem Solving and Innovation:

• Every new product requires Regulatory clearance prior to marketing to local standards and needs. Creative and interactive regulatory delivery in the region/market can significantly impact the commercial timing and viability of the GSK CH portfolio. Unlike GSK Pharma, the role will deal with multiple classifications of products (not just medicines, but devices. cosmetics and foods) requiring additional learning agility and application of knowledge under very different regulatory frameworks.
• Every registration requires maintenance, artwork updates and promotional reviews that ensure compliance in each market against the prevailing regulation set.  Changes in supply, company legal entity, derogations, changing regulations (e.g. sales restricted to Pharmacy/Rx, inability to advertise, inability to use target branding, inability to register manufacture at GMS-preferred site) are all complexities that must be managed.

Examples:

• Our oral care innovation as cosmetic had limited claims (answer: develop a medical device strategy)
• Medicinal product registration administratively impossible with Manufacturing Licensed entity (answer: set up a separate local Legal Entity).
• Cosmetic product claims not permitted by advertising regulation  (answer: reclassify legal status of product and achieve registration)

Requirements
Basic qualifications:

• Life Science/Pharmaceutically-related Science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
• Regulatory professional at this level must be highly skilled in scientific interpretation/evaluation/communication of technical information
• RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP
• Regulatory Affairs, Pharmacy

Preferred qualifications:

• Position requires practically-applied demonstration of intellect and an ability to interface effectively with  internal and external stakeholders (other commercial and technical staff, local senior management, external regulators, trade associations).