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Associate Director Global Regulatory Affairs - International

Bracknell, United Kingdom

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Req ID R-34439 Title Associate Director Global Regulatory Affairs - International City Bracknell Country United Kingdom Region Research

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Job Purpose:

Lilly’s International Regulatory Affairs team are laser focused on providing world class regulatory support to a variety of programs across the portfolio of products. This team, made up of thought leaders, technical specialists and strategic experts are responsible for the creation, submission, approval, and maintenance of high-quality dossiers to regulatory bodies across the International Business Unit. By joining the team as an Associate Director, you will be working in a role which has impact and provides opportunities to learn from well-respected industry figures.   

The purpose of the Associate Director role is to be responsible for submission, approval, maintenance of:

  • At least one significant line extension of a major Lilly product without management support
  • At least one major Lilly product with broad, direct management support.

It is anticipated that 70% of the role will focus on critical EU markets. The Associate Director will ensure dossiers of the highest possible quality are produced efficiently and ensure the unique dossier requirements of the countries in the IBU (other than EU) are considered and that high quality dossiers for all the IBU markets are delivered.

You may also perform regulatory evaluation of external business opportunities with minimal management supervision and manage alliance/CRO relationships in the regulatory area. As an Associate Director you will develop and drive regulatory strategy, representing that strategy to key Lilly groups /governance committees while also representing the regulatory function on cross-functional non-product related projects with some guidance.

Primary Responsibilities:

GRA-Int:

  • Liaise with the affiliates to anticipate country specific issues, impact of the SPC on promotion, in pricing and reimbursement, etc. Be an efficient liaison between the affiliates and corporate (product team, GRA-CMC)
  • Give direction to the affiliates on the interpretation of the regulatory processes and outcomes
  • May have responsibility for managing, training and development of one or more associates or senior associates

Program/Product Team:

  • Have significant input into the Core Label. Ensure the needs for local patients in Clinical Trials are met for countries in the IBU.
  • Provide extensive, up-to-date expertise on European registration procedures
  • Interpret guidelines and anticipate impact of new guidelines
  • Establish EU regulatory strategy and ensure development strategy is in line with regulatory expectations. Development strategy also needs to meet the requirements for all other IBU markets.
  • Execute regulatory strategies for NCEs, line extensions, new indications, etc.
  • Drive appropriate interactions and meetings with agencies and Commission to ensure resolution of issues with timely approval and the best possible SPC
  • Act as regulatory lead for products at later phase of development: facilitate regulatory communication; coordinate agreement on regulatory plan; provide the regulatory timelines to the team

Business:

  • Bring IBU drivers and perspectives to team meetings
  • Influence the regulatory agencies in favor of the planned development
  • Participate in IBU meetings to ensure that regulatory strategy and issues are considered and to learn about business needs. Link technical expertise with business knowledge to influence and impact cross functional initiatives and drive to optimum solutions
  • Advise on the regulatory consequences of proposed regulatory action
  • Provide awareness of current registration environment and work to influence to Lilly’s advantage when possible

Minimum Qualification Requirements:

Influence/Interpersonal Skills:

  • Influence complex regulatory issues within the function
  • Influence across disciplines through technical expertise
  • Effectively defend IBU perspective with the global team
  • Lead teams to resolve regulatory issues with minimal supervision
  • Guide teams through multiple development stages
  • Be familiar and open to cultural diversity. Embrace different styles of working

Technical Knowledge:

  • Bachelor’s, master’s degree or PhD in a Life Science Subject 
  • Deep understanding and knowledge of European regulations and procedures in other IBU countries
  • Understand and knowledgeable across more than one therapeutic area
  • Able to apply knowledge and across several stages of drug development
  • Strong experience in regulatory affairs (authority or industry) and/or extensive experience in a research-based drug development role with regulatory affairs exposure

 Innovation:

  • Anticipates and resolves key technical issues that impact the function
  • Problem solving and creativity in the regulatory area
  • Introduces new ideas, multiple solutions, concepts, or different approaches to projects

Communication:

  • Presents effectively at internal and external meetings
  • Can listen, understand, and interact with co-development partners with differing expectations and objectives
  • Efficiently plans, influences, leads, and follows up meetings within Lilly to address regulatory issues
  • Writes clear, concise, effective regulatory and business documentation
  • Capable of building a network of contacts in Lilly

Self-Management:

  • Ability to work independently and in teams
  • Good time management skills
  • Broadly self-reliant, requiring little management supervision on all but key strategic issues

 Decision Making:

  • Makes clear well-thought-out decisions that impact the function and geography based on considerable expertise and fine judgement

Impact:

  • Drives solutions impacting results within the company with minimal supervision

 Project Management:

  • Leads large-scale projects with greater risk and/or complexity

About Lilly:

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that met real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-34439.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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