Regulatory Affairs Manager Job at GlaxoSmithKline (GSK)
GlaxoSmithKline (GSK), one of the world's leading research based
pharmaceutical and healthcare companies, is committed to improving the
quality of human life by enabling people to do more, feel better and
live longer. GSK employs over 97,000 employees in over 100 countries
worldwide.
GlaxoSmithKline Consumer Nigeria Plc is one of Africa's largest consumer
healthcare companies, producing leading brands such as Lucozade,
Ribena and Panadol.
GlaxoSmithKline (GSK) is recruiting to fill the position below:
Job Title: Regulatory Affairs Manager
Requisition ID: WD80623
Location: Lagos
Position: Full time
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
- 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
- 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
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
- 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.
- 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)
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)
- RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP
- Regulatory Affairs, Pharmacy
- Regulatory professional at this level must be highly skilled in
scientific interpretation/evaluation/communication of technical
information
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)
How to Apply
Interested and qualified candidates should:
Click here to apply