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

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

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. 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 response to questions in EMEA region.
• Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content.
• Partners with EMEA-regional colleagues and makes decisions on CMC regulatory strategies impacting product submissions across EMEA region and networks for alignment with CMC team members.
• Proactively identifies and resolves EMEA-regional CMC regulatory issues, leveraging internal experts and/or management to develop complex regulatory strategies.
• Develops relationships with personnel in other Lilly functional areas (i.e., PR&D and M&Q, etc.) that promote open discussion of issues with a demonstrated ability to influence drug development strategies.
• Ensures timely EMEA regional submissions.
• Communicates effectively to influence within work group/function, with development team, GRA, GRA-CMCD team, RDE, and the affiliates.
• Participate in forums that share EMEA-regional regulatory information across GRA components.
• Participates in the development of corporate positions on, and responses to, proposed agency regulations and guidelines.

Minimum Qualification Requirements:

• Minimum a college degree (BSc), ideally an advanced degree (MSc, PhD, PharmD preferred), in related biological and life science field (e.g., chemistry, biology, biochemistry or pharmacy)
• Minimal 4years of pharmaceutical industry experience in technical drug development and/or medical device

Other Information/Additional Preferences:

• Prior experience authoring CMC submission content.
• Prior Regulatory CMC experience (5-8 years) or equivalent combination of technical and regulatory guidance knowledge.
• Full professional proficiency in English (written and spoken).
• Demonstrated strong written, spoken and presentation communication skills.
• Demonstrated negotiation and influence skills.
• Demonstrated attention to detail.
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.