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’. There are so many reasons to join us. 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.  

Being part of #TeamBayer means that you are part of our vision and of our future – delivering to our farmers, patients, and consumers. 

 https://www.bayer.com/en/strategy/strategy

Regulatory Affairs Manager

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 and 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 and the role of digital to expedite development pathways and improve patient experiences. This is 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. ACCESS collaboration drives five stringent regulatory authorities (UK, Australia, Singapore, Switzerland, Canada) to align on regulatory policy and licensing decisions to facilitate access to patients through collaboration and work-sharing. The ACCESS RAM performs the co-ordination role as required across the 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 and to advise and agree on regulatory strategy and data requirements.
• Critically evaluating submission packages in line with regulatory requirements to eliminate deficiencies prior to construction and submission of MA applications withing agreed timeframes.
• Preparing high quality, licence applications to gain approval for clinical trials and the marketing of products, and to maintain existing licences and product information according to statutory requirements. Ensuring applications meet UK national, EU and internal compliance requirements.
• Monitoring and influencing the assessment process to expedite and optimise the outcome of their submissions. Driving negotiations with MHRA to ensure best possible outcome which may include, for example, optimal product labelling or assurance of supply continuity and delivery of their commitments and deadlines.
• 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) as one of the must win countries for new asset development.
• 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. Proactively contribute to and engage with internal and external networks.
• Advise local teams and regional/international colleagues on regulatory topics, intelligence & policy and submission strategies, presenting available options and making recommendations.

Key Tasks

• Strategic regulatory leadership of assigned products.
• Actively contributing on UKRA input into global meetings (pipeline development), with regards to current and future regulatory changes and making proposals to Head RA UKI on product regulatory strategies.
• Acting as RA Lead for the management, preparation and submission of new MAAs, ILAP Innovation Passports (IP) / Target Development Profiles (TDP), UK PIPs and other local submissions as assigned. Leading Health Authority meetings for local activities such as pre-submission meetings, HA pipeline meetings, HA clarification meetings, UKI Policy topics.
• Assuming the role of NAE member for specific products / therapy areas representing UK Regulatory as one of the must win countries for new asset development support. This includes providing information on the Regulatory environment, shaping early development decisions and providing aligned input for strategic development decisions. 
• Providing regulatory advice and support for divestment and in-licensing opportunities.
• Independently managing new MA submissions, e.g. Scientific Advice meetings, attendance at launch meetings, pre-vetting materials and stock readiness.
• Proactively liaising with MHRA and global regulatory and ensuring prompt professional responses to questions are provided to meet the earliest possible approval timeframe.
• Preparing, co-ordinating and submitting high quality, MA applications, life cycle management activities, CTA applications and modifications, according to national/EU requirements (including renewals, variations, expert statements). Maintaining medicine dossiers and medical device technical files within agreed portfolio to statutory requirements.
• Being accountable for the content of local label documentations released to prescribers and patients, ensuring the quality of documentation is optimised and that potential regulatory hurdles to successful UK launch are identified, minimised and documented. Checking incoming documentation from global RA colleagues to ensure MAs and CTAs comply with HA guidance (e.g. HMRs and UK CTR).
• Submitting and maintaining official local medicines information, including SmPCs, Patient Information Leaflets, packaging texts, RMPs and any associated Educational Material.
• Creating, compiling and submitting applications to any other authorities (e.g. HSE or EPA gene therapy trials) as required.
• Providing information on regulatory procedures, competitors, guidelines and policy to effectively advise Head of RA UKI, global regulatory and the brand teams / therapy areas. Keeping Head RA UKI fully informed on key project-related topics.
• Partnering with local and global teams to provide regulatory strategic and technical expertise for submissions, HA interaction and brand strategy.
• Understanding and proactively communicating with internal stakeholders about the impact of regulatory information and intelligence relevant to the Pharma business. Promoting awareness of regulatory requirements within brand teams and with other key stakeholders. Developing positive relationships with key stakeholders and proactively identifying opportunities to add value to customers. Effective communication with UK cross functional team members to ensure UK strategy is clear.
• Ensuring communication of any regulatory changes to the business as necessary to support licence compliance with prompt circulation of approved documents to appropriate personnel and efficient maintenance of Regulatory files and databases. 
• Working closely and swiftly with cross functional teams to address critical issues, e.g. batch recall or other batch release issues.
• Leading the adoption and implementation of new systems and processes to streamline routine regulatory activities. Being an ambassador for UK RA by managing key regulatory challenges and pro-actively highlighting potential impact of external changes on internal processes.
• Participating in Quality System Document (QSD) review process and updating QSDs related to principal accountabilities as required.
• Ensuring an on-going commitment to self-education, professional development and training (Continuing Professional Development (CPD)).

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, encompassing CMC, Clinical and Commercial aspects in the ethical pharmaceutical industry
• Commercial awareness and a good scientific knowledge of the therapeutic areas that Bayer operates within.
• Leadership and influencing skills to manage numerous stakeholders and lead cross functional teams
• Excellent communication skills including proven ability to influence by persuasion and, where appropriate, negotiation, including good presentation skills.  Proven ability to communicate complex information to all levels / different audiences (non-technical personnel).
• Strategic thinker with proven ability to formulate, develop and execute strategies.
• Ability to work autonomously in planning and execution with proven ability and courage to take decisive action based on sound regulatory knowledge. Ability to use technical skills in innovative ways.
• Along with experience of regulatory affairs for medicines, it would be desirable to have some knowledge or experience in medical devices.
• Proven people management skills & team engagement are important for this role in terms of managing relationships within the Regulatory Affairs Team, with global SMEs and participating in cross-functional teams at both a local and regional/global level.
• Ability to manage complexity and ambiguity in a changing environment. To learn and maintain knowledge of a technically and legally complex area (commitment to CPD).

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

Your Application:

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

To achieve our vision we see reward for all our employees as incredibly important, so here are some of the benefits you will receive as a Bayer employee. 

What we offer

• Competitive compensation package consisting of an attractive base salary and annual bonus.  Individual bonus can also be granted for top performance awards.
• 28 days annual leave plus bank holidays
• Private Healthcare, generous pension scheme and Life Insurance
• Wellness programs and support
• Employee discount scheme

• State of the art offices 
• International career possibilities
• Flexible and Hybrid working
• Help with home office equipment
• Volunteering days
• Support for professional growth in a wide range of learning and development opportunities
• We welcome and embrace diversity providing an inclusive working environment

The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.

#LI-UK

#Hybrid

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. We continue to progressively embrace and adopt actions to advance our Diversity Equity & Inclusion (DE&I) commitments and aspirations, #ForBetter.

Bayer is committed to providing access and support for all individuals with disabilities and / or long term conditions - during the application process and beyond. Let us know if there is anything about the recruitment process that you would like to discuss, in particular if there are any changes or adjustments that would make it easier for you to apply please contact HROP_UK@bayer.com.

Location:

United Kingdom : Berkshire : Reading  

Division:

Pharmaceuticals 

Reference Code:

842124