Senior Regulatory Affairs Manager

Role Purpose

You will manage a team responsible the regulatory support for a number of marketed products and development compounds in UK, Ireland and Malta, in line with local and global business objectives, relevant regulatory requirements and internal and external standards.

Key to this role is the ability to develop, communicate and implement effective UK regulatory strategies for assigned pipeline products and line extensions in conjunction with relevant internal and external stakeholders.

Accountabilities

• Responsible to provide and oversee full regulatory support for assigned licensed products in UK, Ireland and Malta across the full life cycle, from pre-launch, launch, maintenance, discontinuation, and divestment in line with the direction and strategy agreed with the local business and GRA. Includes the preparation and submission of licence variations, implementation of SmPC and pack copy updates, the preparation and implementation of prescribing information, PIP related submissions and, where applicable, device registrations.
• Responsible to provide full regulatory support for assigned clinical trials in UK and Ireland. Includes the preparation and submission of new trial applications, preparation and submission of substantial amendments, Urgent Safety Restrictions and submissions of DSURs
• Develop and maintain with appropriate stakeholder input the local Regulatory Strategy for assigned development compounds or significant line extensions. Provide regular regulatory input on status and strategy to local or corporate colleagues and represent the department in Asset team and Launch Readiness meetings as required.
• Maintain an in-depth awareness of new legislation and guidance and assess the impact on local business activities. Support the Regulatory Intelligence process by ensuring local management, business partners and global RA functions are made aware of relevant developments. Participate in relevant national trade association meetings and working groups and establish and maintain close relationships with relevant national Health Authorities and other external stakeholders to facilitate effective collaboration on all regulatory interactions and to promote the interests and image of Boehringer Ingelheim.
• Lead a team of direct reports with responsibility for their day to day line management, operational support and the setting of standards and actively supporting the team’s development.
• Contribute fully to CAPA processes and support internal Audits and Regulatory inspections leading on assigned topics as required.
• Deputise for the Head of Regulatory Affairs as required.

Experience and competencies

• Significant, broad, up to date, hands on experience gained over several years of managing regulatory submissions in a similar regulatory environment within the pharmaceutical industry. Ability to work independently and manage more complex, or novel projects or areas or work.
• In depth knowledge of European procedures from a local affiliate perspective
• Excellent business and strategic awareness
• Strong planning and prioritisation skills, able to manage and oversee a heavy and varied workload with multiple conflicting priorities. Responds quickly and positively to changes, showing an agile, can-do attitude. Results driven with a strong sense of personal accountability.
• Proven ability to work as part of a multi-disciplinary team, developing positive working relationships.
• Excellent written communication skills with attention to detail. Ability to critically appraise and summarise guidelines and scientific information.
• Strong interpersonal and influencing skills, able interact with stakeholders at all levels in a credible manner
• Experience of or aptitude for managing and developing individuals and teams, promoting a high performance culture.

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths – and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after – as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you’ll be helping to transform lives for generations.

Want to learn more? Visithttps://www.boehringer-ingelheim.com