Regulatory Strategy & Innovation Lead EU, Open to flexible working
The Regulatory Strategy & Innovation Lead for Europe provides regulatory leadership, strategic direction and managerial oversight, ensuring delivery of agreed innovation, maintenance of existing business, ensuring compliance and proactively leading external engagement in the regulatory environment for pan-European medicines, medical devices, dietary supplements & cosmetics.
- Leads regulatory teams in development and execution of highly effective regulatory strategies for above-country procedures, including oversight of regional HA & industry interactions.
- Has direct reporting responsibility for each of the Regulatory Innovation Leads for the 4 European Business Units (BUs), in addition to 5 EU Regulatory Strategists
- Provides key strategic input to R&D and Commercial teams, ensuring consistent quality standards for regulatory processes and deliverables to meet business objectives.
- Leads regulatory due diligence as appropriate and oversees key innovation regulatory activities and geographical expansion.
- Develops the capability of the regulatory team and builds regulatory knowledge and insight across the above-country team.
- Leads and enables partnerships within the wider technical organisation (GSK Reg, GCMC, R&D, Quality) and other functional areas, ensuring regulatory positions and planning priorities are aligned to achieve organisational goals and strategies.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
People, Capabilities, Leadership:
- Leads above-country regulatory activities and provides leadership, strategic direction, clear objectives/priorities and managerial oversight.
- Manages in-scope regulatory resources.
- Ensures long term collaboration and engagement with external consultants/distributors and across the wider regulatory organisation.
- Directs the growth and professional development of above-country regulatory team, including succession planning for critical roles across the wider regulatory organisation.
Regulatory Strategy & Innovation
- Development and execution of highly effective regulatory strategies to meet European BU business objectives.
- Manages Regulatory Innovation Leads for the four European business units, supporting delivery of local innovation in line with BU targets
- Provides regulatory knowledge and leadership to innovation/digital initiatives (principles, process and application) and oversees negotiations with regional HAs, as appropriate.
- Manages above-country registration plans and ensures objectives for new registrations are aligned to BU objectives and priorities.
- Oversees lifecycle management to ensure maintenance of EU registrations and compliance.
Regulatory Interaction, Influence & Communication:
- Manages activities to proactively shape key regional legislation, working closely with the industry associations and other relevant stakeholders in key countries.
- Oversees the development of strong working relationships with key agencies in the area/region or industry.
- Builds regulatory knowledge and insight in the region.
- Accountable for building and enhancing regional regulatory intelligence processes and coordinating sharing of regulatory and competitive intelligence to contribute to the global knowledge / regulatory insight.
- Ensures input to the development of regulatory perspectives and/or strategies for Europe.
- Ensures impact assessments completed and provides proactive communication and advice to the business partners on existing and emerging regulatory trends and requirements.
Regulatory Compliance and Best Practices:
- Ensures full compliance and conformance with all government regulations, requirements and guidelines in the region.
- Ensures adherence/compliance to corporate policies, inspection readiness, SOPs and regulatory system compliance (data reporting accuracy).
- Accountable for resource capacity and capability management across above-country team.
We are looking for professionals with these required skills to achieve our goals:
- Significant experience in Regulatory Affairs including:
- Demonstrable delivery of innovation through industry-leading Regulatory strategies
- Extensive experience leading & managing European Regulatory procedures
- Proven track record influencing the external environment
- Experience across consumer healthcare product classifications including medicines, medical devices, dietary supplements & cosmetics
- Ability to develop pathways from ambiguous situations and adapt to frequent change
- Strong entrepreneurial drive & demonstrable creativity
- Excellent communication & negotiation skills at multiple organisational levels
- Ability to oversee the functioning of large, complex cross-functional initiatives in a matrix organisation
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please submit a cover letter with your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information provided in your cover letter and CV will be used to assess your application.
Closing date for applications: 21st of January 2022
Thank you for your interest in this opportunity!
Why Consumer Healthcare?
Right now, we’re on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We’re doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year – over a billion and a half of them – and it goes beyond products. It’s about truly helping people manage their health proactively in different ways as consumer needs evolve.
With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.
This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.
Diversity, Equity and Inclusion
In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.
We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.
Recently we’ve shared some exciting proposals with our colleagues which mark an important moment in our preparations for separation and becoming a new, standalone Consumer Healthcare company.
Our preparations are going well. GSK is on track to separate in mid-2022 and create two incredible new companies, each with the ability to improve the health of millions of patients and consumers worldwide, and both great places to work.
We’ve already confirmed that our new Consumer Healthcare company will be headquartered in the UK and the first step we’re taking is to announce proposals to move our CH business from our current location in GSK House in Brentford when we separate, into a new, CH headquarters in Weybridge. This will be a temporary, but important move in the short term, whilst we take this opportunity to design for the future and create an inspiring, flexible, collaborative workspace that meets the changing needs of our people and our business needs.
Inspired by our new culture and purpose, and with a commitment to our sustainability goals, we plan to build a new campus close by which would be home to our headquarters teams, our UK business, our global Oral Health category, R&D and innovation teams, as well as a state-of-the-art Shopper Science lab
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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