Sr. Principal Scientist, Advisor, Sr. Advisor of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices-EMEA

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

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.

Purpose:

The purpose of the Sr. Principal Scientist, Advisor, Sr. Advisor of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices-EMEA (GRA-CMCD-EMEA) is to provide strategic, tactical, and operational direction to expedite CMC development of Lilly’s portfolio and to develop successful regulatory strategies to support market registrations and product life-cycle maintenance in EMEA region including markets such as EU and CEE countries, META region, Switzerland, and the United Kingdom. etc. This is accomplished with a strong working knowledge of global and EMEA-regional regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of development and manufacturing processes. To accomplish this purpose, it is necessary for the scientist to develop collegial and mutually productive relationships across Lilly components, partner with broader GRA-CMCD, GRA regional teams and regional affiliates, Manufacturing and Quality (M&Q), and Product Research & Development (PR&D).

Primary Responsibilities: 

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Regulatory & Scientific Expertise

• Demonstrated technical knowledge and understanding of CMC drug development science(s), drug substance and drug product manufacturing, manufacturing quality systems and compliance expectations.
• Recognized within the company for working knowledge of EMEA-regional CMC regulatory requirements and guidelines for product registrations in EMEA region.
• Manages the development of regulatory strategy and updates strategy based upon regulatory changes.
• Provides high quality, timely and decisive regulatory advice to allow CMC teams to make well-informed decisions on development or product lifecycle planning.
• Evaluates regulatory impact of proposed CMC development plans and post-approval change agenda.
• Reviews CMC documents for submissions in the EMEA region, and networks with GRA-CMCD to assess impact of submissions for manufacturing changes, new products, or line extensions.
• Anticipates and resolves key technical or operational issues that could impact the function or CMC team.
• Participates in risk-benefit analysis for regulatory compliance.

Influence

• Networks throughout GRA and GRA-CMCD including GRA-International Operations, as appropriate, building awareness and alignment on CMC Regulatory strategies.
• Provides EMEA-regional regulatory guidance to GRA-CMCD, CMC and regional affiliates and implements regulatory strategies that result in successful product registrations.
• Exhibits strong leadership behaviors and is sought out as a functional mentor or peer coach within GRA.
• Incorporates new regulations, guidance, and company positions into GRA-CMCD processes/guidelines, tools, and/or training materials.
• Influences internal policy development and provides internal input on emerging regulations in EMEA region for CMC issues.
• Participates in industry organizations to increase Lilly’s visibility and influence of evolving regulatory positions.

Leadership, Collaboration and Partnering

• Coordinates preparation, review, and finalization of CMC documents for registrations and respon