Job Description

Regulatory Scientific Strategy Manager

Bristol

About Us

We are a truly international company, fourth largest in our industry and operating across 120 markets. An inclusive, innovative global FMCG business supported by over 27,500 employees. As we embrace a new era of growth, we are transforming. Our ways of working and culture are driven by a challenger mindset, constantly questioning the status quo. Our agility and entrepreneurial spirit, alongside award winning development programmes, enable innovation and success while creating exciting and rewarding career choices. As we move forward, our customers will be at the heart of what we do, evolving to needs and expectations and committing to a more meaningful contribution to harm reduction by building a successful NGP business. Integral to our long-term success is our sustainability strategy, behaving responsibly and supporting our ambitions, all underpinned by high governance. Encouraging inclusion at local levels and supporting a developing and robust diversity agenda globally, we are fully committed to creating and maintaining an environment that celebrates and respects difference.

The Role

In this role you will be defining the strategy for the regulatory scientific testing framework for all Next Generation Product (NGP) categories, globally, ensuring a consistent approach, to secure favourable regulatory outcomes for IMB’s commercial choices.

The strategy will encompass the “what”, “where”, “when” and “how” elements for all scientific and regulatory programmes, working with internal and external stakeholders such as Labs, Operational Science and Safety, Product Safety and Compliance, Harm Reduction and Engagement and CRO’s, to clearly define what is required to launch in each market, in a costly and timely manner, in line with Business plans.

The role is responsible for driving and leading the scientific strategy for all NGP related activities for US launch projects, ensuring that necessary Duty of Care requirements are conducted to enable on time and successful product launches in line with commercial plans. Furthermore, the role holder will lead on developing and implementing the scientific testing framework for US launch projects, such as Pre-Market Tobacco Applications and Modified Risk Tobacco Applications (MRTP). For NGP product launches in pre-authorisation markets (ex US), the role is responsible for defining the scientific activities to meet regulatory requirements.

The Regulatory Scientific Strategy Manager is a collaborative role in which a matrix way of working with stakeholders from multiple areas of the business is critical, as success is delivered via Subject Matter Experts (SMEs) that are not direct reports. The role holder will work closely with Labs, Operational Science and Safety, Product Safety and Compliance, Harm Reduction and Engagement, Category, ITGB, markets and CRO’s.

Principle Accountabilities

• Scope: Global
• Define and own the scientific testing framework to ensure consistent approach to scientific substantiation and clear and consistent messaging through regulatory dossiers.
• Lead on the development and implementation of the scientific strategy, ensuring clear research requirements for regulatory submissions for all product categories, with a specific focus in US for EVP, working collaboratively with ITGB, Harm Reduction & Engagement, Product Safety & Compliance team, and NGP Science Managers.
• Creates & drives the scientific workstream to support new product launches in line with commercial plans (such as PMTA) and supports defence of current products to ensure ongoing commercial viability.
• Demonstrate best-in-class cross-functional organization, communication and management between multiple teams in different departments. Be a conduit to experts to align on strategic directions, and other departments to ensure compliance and submission in line with NGP regulations.
• Possess comprehensive understanding of product categories and regulations and keep informed with regulatory/ scientific developments relating to product portfolio.
• Contribute to the education of internal stakeholders and broader employees on the science behind Imperial’s NGP offerings.

Key Relationships

Internal

• Director of Group Science & Regulatory Affairs
• Head of Scientific and Regulatory Affairs
• PMTA Programme Team
• Regulatory Reporting Team
• NGP Science Managers
• Group Legal
• ITGB

External

• Consultancies, contractors, suppliers, regulators

Key Skills & Experience

• Educated to degree level, or equivalent, in a relevant scientific discipline
• 5+ years’ experience in Scientific and/or Regulatory Affairs
• 5+ years’ experience designing and delivering pre-clinical or clinical studies
• Experience preparing and submitting dossiers to global regulators
• Experience as a Scientific Project/Programme Manager, delivering multiple scientific studies, in a relevant industry sector or subject area
• Ability to identify, adapt and apply best practice in all aspects of project/programme management
• Successful commercial experience negotiating/working with external suppliers
• Extensive knowledge of NGPs, nicotine and tobacco science and public health issues
• Attention to detail
• Strategic thinker
• A proven ability to meet deadlines
• Can operate effectively in collaborative and directive business environment and able to develop broad, cooperative relationships with a set of diverse stakeholders
• Self-motivated, independent and proactive
• Excellent oral and written communication and interpersonal skills

What We Offer & Next Steps

Competitive salary, bonus scheme, pension, and 25 days holiday (with an additional 4 days on top to cover the Christmas period, and bank holidays), flexible working policy, corporate discounts, Health Cash Plan, and other wellbeing initiatives.

Next Steps

Interested applicants are encouraged to apply, highlighting their suitability for the above post.