Senior Director Global Regulatory Affairs-EMEA

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 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.

Title: Senior Director, Global Regulatory Affairs-EMEA

Reports to: Associate Vice President-Global Regulatory Affairs

This role requires working from the affiliate office on weekly basis

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 meet 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.

ROLE OVERVIEW:

As the Senior Director, Global Regulatory Affairs (GRA)-EMEA you will be accountable to establish the local regulatory strategy and plan for assigned product(s) in the region/country. Very importantly you will ensure that the local plan aligns to the global regulatory strategy.

It will be your responsibility to provide regional regulatory leadership and oversight in delivering high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s). You will lead meetings and other interactions with region/country regulators.

PRIMARY RESPONSIBILITIES INCLUDE:

Regulatory Expertise for Assigned Program/Product(s) in Region/Country

• Provide region/country input and review of global strategic plans and global/regional submission plan and documents.
• Contribute during key governance committees on regional regulatory strategy decisions, if requested (e.g. when key discussion topics impact the region).
• Ensure approval and delivery of content for local regulatory submissions.

• Own relationship and lead meetings and interactions with regulators in assigned region and engage cross functional partners to contribute to regulator interactions.
• Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling in region/country.
• Ensure compliance with all applicable regulations and internal quality systems.

Lead, influence and partner

• Partner with Global Regulatory Leads to help solve development and regulatory issues and ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and executed.
• Liaise with the affiliates to anticipate region/country specific issues, impact of labelling on promotion, pricing and reimbursement.
• Participate in regional meetings (commercial managers, medical directors) to ensure that regulatory strategy and issues are considered and to learn about their needs.
• Lead or represent the regulatory function on cross-functional non-product related projects
• Serve as a mentor for GRA personnel.

MINIMUM REQUIREMENTS:

• Advanced scientific degree (i.e., PhD, MD, PharmD) or bachelor’s with significant relevant industry-related experience in regulatory affairs and/or drug development
• Industry-related experience in regulatory affairs and/or drug development experience
• Knowledge of local/regional regulatory procedures and practices
• Awareness of evolving regulatory reform initiatives, preferred

EMBRACING DIVERSITY:

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.

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Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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