Sr. Scientist, Principal Scientist, Sr. Principal Scientist, Advisor, Sr. Advisor – GRA-CMC-Asi[...]

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. Scientist, Principal Scientist, Sr. Principal Scientist, Advisor, Sr. Advisor – GRA-CMC-AP role 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 Asia Pacific (AP) including Japan, China, Australia, New Zealand, Korea, Taiwan, Singapore, ASEAN Alliance and India. This is accomplished by a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with 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, coordinate with Japan and China regulatory colleagues, partner with company representatives and regional regulatory agency personnel. This role is further accomplished by a demonstrated ability to establish and/or to promote/refine key regulatory CMC positions and to effectively influence business units, M&Q and GRA leadership on these positions.

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

• Good 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 AP-regional CMC regulatory requirements and guidelines for product registrations in AP 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 AP region, and networks with GRA-CMC and manufacturing site regulatory scientists 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 Global Regulatory Affairs, as appropriate, building awareness and alignment on CMC Regulatory strategies.

• Provides AP-regional regulatory guidance to GRA-CMC, CMC and IBU teams and implements regulatory strategies that result in successful product registrations.

• Exhibits strong leadership behaviors and is sought out as a functional mentor within GRA.

• Incorporates new regulations, guidance, and company positions into GRA-CMC processes/guidelines, tools, and/or training materials.

• Influences internal policy development and provides internal input on emerging regulations in AP 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 AP region.

• Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content.

• Partners with Japan, China, and AP-regional colleagues and makes decisions on CMC regulatory strategies impacting product submissions across AP region and networks for alignment with CMC team members.

• Proactively identifies and resolves AP-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, toxicology, TS/MS, quality, RA-CMC within Japan, and China affiliate etc.) that promote open discussion of issues with a demonstrated ability to influence drug development strategies.

• Ensures timely AP regional submissions.

• Communicates effectively verbally and in writing to influence within work group/function, with development team, GRA, GRA-CMC team, RDE/LCCI, and the affiliates.

• Participate in forums that share AP-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 4 years 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 (4-7 years) or equivalent combination of technical and regulatory guidance knowledge.

• Fluency in English and AP-regional language(s).

• 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.