Area Regulatory Affairs Manager (Compliance) at GlaxoSmithKline Plc (GSK)

Job Purpose

This position has responsibility for Africa Regulatory Affairs Compliance activities across all portfolios or activity streams. The role may also have responsibility for leading a team of regulatory professionals within their country. This includes

• Ensure products within scope (inc medicines, devices, cosmetics and foods) are compliant from an OPAL and regulatory tracking perspective.
• Champion the Regulatory Intelligence initiatives to ensure E2E management of regulatory compliance.
• Ensure products are maintained and meet internal and external compliance requirements through applicable metrics
• Be a productive part of defined area regulatory team, including being a proactive partner to other stakeholders, eg, local regulatory team, marketing/sales within local commercial business, supply chain and quality etc.
• Engage with the external regulatory environment within defined area of responsibility and act as a responsible voice of GSK CH with local regulators, trade associations and other key external regulatory bodies on key projects.
• Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives.
• Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope
• Ensuring that that Africa Risks are managed proactively.
• Champion Labeling, OPAL and scorecard initiatives across Africa.

Key Responsibilities

Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role

• Develop and manage the Africa Regulatory KPI’s and Dashboard to be shared with key stakeholders on a quarterly basis.
• Ensure optimal Regulatory Compliance levels for Africa through defined metrices
• Communicate with key area stakeholders highlighting any regulatory issues, and develop plans to mitigate at concept stage by ensuring open and transparent communication with the markets so that we can deliver science that is robust and aligned with business needs
• Execute the Annual coordination of renewals for the Area (OPAL uploads) including tracking the process through to submission dates (E2E). Providing necessary OPAL support to the markets.
• Proactively manage the impact of regulatory changes on the business with the Area Director.
• Create/track metrics/dashboards (RFT dossiers/dispatch to file dates/approvals/launches) for the Africa area
• Embed a framework in-place to measure and track Regulatory Affairs (RA) performance quality processes
• Track and monitor the risks identified for the Africa region
• Ensure Area visibility at all times of database systems’ content, ensure data maintenance activities are performed in line with high GMP standards, updates made accurately & in a timely manner (Responsible to Run regular checks on OPAL/ZINC/HARMONY/AGILE and report back to prime & secondary stakeholders adherence levels)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
• Champion the Labelling compliance initiatives in Africa ensuring an E2E compliant process.
• Analyse 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
• Liaise with central Labeling on GLC approvals (i.e. a “heads up” to markets in advance of GDS dispatch)
• Monitor CLDs (L1?)

Knowledge/ Education / Previous Experience Required*

Educational Background
Minimum Level of Education

Bachelor's Degree: Area of Specialisation* Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)

Preferred Level of Education

• RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP
• Area of Specialisation: Regulatory Affairs, Pharmacy
  

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)

Job-Related Experience

Minimum Level Of Job-Related Experience Required

Ideally a minimum of 10 years’ experience in Regulatory Affairs, however this will vary between markets depending on availability of regulatory talent

Why is this Level of Experience Required?

Regulatory clearance is a pre-requisite of any product marketing. Compliance to regulatory requirements and management of health authorities is essential to Corporate compliance and product portfolio/sales maintenance. Ability to effectively communicate and negotiate in relation to technical information and regulations is key.

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.

• 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)

Needs to be able to work independently, or as part of a team to monitor and analyse market trends within defined scope of responsibility, and advise on potential impact to GSK (e.g. ingredient status change) with proactive solution proposals.

Needs to also work individually or as part of a team to proactively manage issues, for example new regulatory processes that could hamper advertising and promotion.

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.

Multi-Cultural

Whilst the role will mostly exist within a single market, there will be regular need to effectively communicate and achieve outcomes with regulatory peers and other stakeholders across a range of other geographies

Impact

• Regulatory approvals and compliance are critical business enablers for innovation, advertising and promotion and continuity of on-going business. Issues in any of these areas can severely impact the business and can result in significant loss of sales and reputation.
• This role operates to support the Commercial Teams within an Area/Market to
  
  
  • create and deliver dossiers to deliver regulatory strategies that maximize product opportunity (availability and advertising claims) which drives increased portfolio value (creatively, yet compliant)
  • provide high quality reactive and preventative maintenance of the core business (to ensure longevity of what has already been achieved)

Execution of regulatory strategy impacts commercial value either positively (new approvals, increased access) or negatively (e.g. recalls, inability to supply, license withdrawals).

This position may sit on Local commercial project teams or quality teams at Commercial Area/Market level to deliver regulatory dossiers and outcomes.