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.
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 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 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.
* 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 within 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.
* Monitoring and influencing the assessment process to expedite and optimise the outcome of their submissions. Driving negotiations with MHRA to ensure best possible outcome.
* 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.
* 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.
* 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.
* Providing regulatory advice and support for divestment and in-licensing opportunities.
* Independently managing new MA submissions.
* Proactively liaising with MHRA and global regulatory.
* Preparing, co-ordinating and submitting high quality, MA applications.
* Being accountable for the content of local label documentations released to prescribers and patients.
* Submitting and maintaining official local medicines information.
* Creating, compiling and submitting applications to any other authorities as required.
* Providing information on regulatory procedures, competitors, guidelines and policy.
* Partnering with local and global teams to provide regulatory strategic and technical expertise.
* Ensuring communication of any regulatory changes to the business.
* Working closely and swiftly with cross functional teams to address critical issues.
* Leading the adoption and implementation of new systems and processes.
* Participating in Quality System Document (QSD) review process.
* Ensuring an on-going commitment to self-education, professional development and training.
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.
* Experience of Post Brexit Regulatory Environment.
* Broad range of regulatory experience in the ethical pharmaceutical industry.
* Leadership and influencing skills to manage numerous stakeholders.
* Excellent communication skills including proven ability to influence by persuasion.
* Strategic thinker with proven ability to formulate, develop and execute strategies.
* Ability to work autonomously in planning and execution.
* Proven people management skills & team engagement.
* Ability to manage complexity and ambiguity in a changing environment.
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.
What we offer
* Competitive compensation package.
* 28 days annual leave plus bank holidays.
* Private Healthcare, generous pension scheme and Life Insurance.
* Wellness programs and support.
* Employee discount scheme.
The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.
Location:
United Kingdom : Berkshire : Reading
Division:
Pharmaceuticals
Reference Code:
842124 #J-18808-Ljbffr