Pharmaceutical Regulatory Affairs Manager

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Bayer is an organisation where decisions are made together and where innovation cycles are in 90 days sprints. Our operating model (Dynamic Shared Ownership (we call it DSO) is a reimagined way of operating a multinational company which moves at speed and scale with the goal of delivering on our vision.

This role is focused on proficiency in strategy & problem solving, shaping the licensing pathway for UK regulatory approval. To be successful in this role we are looking for an experienced individual contributor, who can successfully operate with minimal supervision.

The role will lead the UK licensing process for assigned Marketed Authorisations (MAs) from early pipeline development, utilising new opportunities offered by MHRA for support of highly innovative products. They also act as a mentor for less experienced Regulatory Affairs Managers (UK or EU).

The Post Brexit UK regulatory system is evolving rapidly and becoming more complex; regulatory strategy is critical to the success of future licences.

The Bayer portfolio is broad, from established products of 20+ years to cell and gene therapies in development, medical devices and combination products, all underpinned by complex regulatory requirements and strategies to ensure Bayer assets meet the fundamentals to successful commercialisation - the Quality, Safety and Efficacy of our assets.

The role includes:

• Management of several MAs to ensure the input of regulatory expertise into decision making of brand teams plus local and global RA management. Identify potential regulatory risks to operational plans and propose options to mitigate risks.
• Lead above country licensing pathway as an ACCESS RAM, coordinating across participating Bayer affiliates and global teams.
• Promoting and fostering close relationships within Pharma UK, Global Regulatory and Health Authorities to ensure Pharma needs and priorities are met.
• Critically evaluating submission packages in line with regulatory requirements to eliminate deficiencies prior to construction and submission of MA applications within agreed timeframes.
• Preparing high quality, licence applications to gain approval for clinical trials and the marketing of products.
• Monitoring and influencing the assessment process to expedite and optimise the outcome of submissions.
• Contributing to continuous process improvements and inspection readiness for both internal process reviews/audits and HA inspections for GxP.
• Representing UK Regulatory in the New Asset Evaluation Team (NAE).
• Act as RA Lead (UK LRAM) in the Global Regulatory Team (GRT) and act as a mentor & role model to other members of the UKI RA team & EU RAMs.
• Advise local teams and regional/international colleagues on regulatory topics, intelligence & policy and submission strategies.

Key Tasks

• Strategic regulatory leadership of assigned products.
• Actively contributing on UKRA input into global meetings regarding current and future regulatory changes.
• Acting as RA Lead for the management, preparation and submission of new MAAs and other local submissions as assigned.
• Providing regulatory advice and support for divestment and in-licensing opportunities.
• Independently managing new MA submissions and proactively liaising with MHRA.
• Preparing, co-ordinating and submitting high quality, MA applications according to national/EU requirements.
• Being accountable for the content of local label documentation released to prescribers and patients.
• Creating, compiling and submitting applications to any other authorities as required.
• Partnering with local and global teams to provide regulatory strategic and technical expertise for submissions.
• Ensuring communication of any regulatory changes to the business as necessary.
• Leading the adoption and implementation of new systems and processes to streamline regulatory activities.
• Participating in Quality System Document (QSD) review process and updating QSDs related to principal accountabilities.
• Ensuring an ongoing commitment to self-education and professional development.

Qualifications, experience and skills required:

• Degree in pharmacy, pharmacology or the biological sciences.
• Experience in UK and EU drug registration activities managing major projects.
• Sound knowledge of worldwide, EU and national regulatory requirements with proven ability to prepare high quality regulatory submissions.
• Experience of Post Brexit Regulatory Environment.
• Broad range of regulatory experience in the ethical pharmaceutical industry.
• Commercial awareness and good scientific knowledge of therapeutic areas.
• Leadership and influencing skills to manage numerous stakeholders.
• Excellent communication skills including proven ability to influence and negotiate.
• Strategic thinker with proven ability to formulate and execute strategies.
• Ability to work autonomously and take decisive action based on sound regulatory knowledge.
• Desirable to have knowledge or experience in medical devices.
• Proven people management skills & team engagement.
• Ability to manage complexity and ambiguity in a changing environment.

To have an organised, methodical approach to work to meet deadlines.

Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.

What we offer

• Competitive compensation package consisting of an attractive base salary and annual bonus.
• 28 days annual leave plus bank holidays.
• Private Healthcare, generous pension scheme and Life Insurance.
• Wellness programs and support.
• State of the art offices.
• International career possibilities.
• Flexible and Hybrid working.
• Help with home office equipment.
• Support for professional growth in a wide range of learning and development opportunities.
• We welcome and embrace diversity providing an inclusive working environment.

Bayer welcomes applications from all individuals, regardless of age, disability, gender identity/expression, family status, pregnancy and maternity, race, religion or belief, sex, and sexual orientation. We are committed to treating all applicants fairly and without discrimination.

Bayer is committed to providing access and support for all individuals with disabilities and/or long term conditions - during the application process and beyond.