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.
