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.
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-LATAM/Canada (GRA-CMCD-LATAM/Canada) 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 LATAM/Canada region including markets such as Canada, Brazil, Mexico, Argentina, Columbia, Chile, Peru, Ecuador, Panama, Costa Rica, The Caribbean etc. This is accomplished with a strong working knowledge of global and LATAM/Canada-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). This role is further accomplished by developing mutually productive relationships with regional regulatory agencies such as ANVISA (Brazil) and COFEPRIS (Mexico) to shape regional CMC regulatory environments and influence regional regulatory framework.
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 LATAM/Canada-regional CMC regulatory requirements and guidelines for product registrations in LATAM/Canada 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 LATAM/Canada 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 LATA/Canada-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 LATAM/Canada 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 LATAM/Canada region.
Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content.
Partners with LATAM/Canada-regional colleagues and makes decisions on CMC regulatory strategies impacting product submissions across LATAM/Canada region and networks for alignment with CMC team members.
Proactively identifies and resolves LATAM/Canada-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 LATAM/Canada 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 LATAM/Canada-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.
Fluent in English, with the ability to work professionally in Spanish and/or Portuguese.
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.
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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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