Sr. Director Regulatory Scientists - Drug Delivery And Digital Health, GRA

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. Director role in Global Regulatory Affairs (GRA) - Drug Delivery and Digital Health provides strategic, tactical, and operational direction to expedite Lilly's drug/device combination products in development. This is achieved by interacting with teams and regulators to develop successful regulatory strategies and submissions in support of clinical trials and market clearance/registrations. It is necessary for the Director to develop collegial and mutually productive relationships across Lilly, partner companies, and with Agency personnel. The Director utilizes drug delivery system, medical device technical knowledge, and regulatory expertise and lessons learned across Global Regulatory Affairs to drive internal consistency and influence effective change management. It is expected that this position embraces corporate transformation initiatives and represent GRA - Drug Delivery and Digital Health as a change ambassador. This is accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of device development process. The Director is responsible for assessing and coordinating communication across GRA on combination product support and developing forums for discussion and development of regulatory positions on new device standards and regulations and impact on the drug molecule. This role is further accomplished by a demonstrated ability to establish and/or to promote / refine key regulatory positions and to effectively influence senior 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

• Deep technical knowledge of and drug/device combination products including systems development science(s).

• Recognized across GRA-NA and GRA-Int'l, DDCS, CMC, and the Business Unit as an expert having a broad technical knowledge of global device delivery system, regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations as well as deep knowledge in one or more specialized areas of regulatory.

• Utilize specialized regulatory expertise to develop and lead implementation of new regulatory practices based on changes in the external environment.

• Independently network and gain alignment with upper DDCS, Business Unit and/or GRA management to resolve complex issues.

• Provide high quality, timely and decisive regulatory advice to allow product teams to make well-informed decisions on development or product lifecycle planning.

• Anticipate and resolve key technical or operational issues that can impact the function, product team and/or submission timing.

• Actively engage in product development activities evaluating data deliverables for scientific rigor and regulatory impact.

• Evaluate regulatory impact on proposed delivery systems

• Independently manage risky (i.e., technically challenging, political) problems and identify creative and/or alternative solutions that support GRA-device objectives and partner requirements.

• Participate in risk benefit analysis.

Influence

• Network independently and throughout Global Regulatory with upper GRA, DDCS, and Business Unit management and Product Team and Development Partner leadership, as appropriate, building awareness and alignment on complex Regulatory strategies.

• Make technical decisions on regulatory issues that set new GRA-Drug Delivery standards impacting product registrations across multiple programs and geographies.

• Establish effective working relationships with Health Authority Device Human Factors reviewer at FDA and interact with global Heath Authorities as required, including key ISO and notified body personnel.

• Recognized as model of strong leadership behaviors and provides mentoring to GRA- Drug Delivery and Digital Health and DDCS staff on technical and/or regulatory topics.

• Provide interpretation and timely internal communication as appropriate for global regulatory news.

• Lead strategic initiatives to incorporate new regulations, guidance, and company positions into Lilly processes/guidelines, tools, and/or training materials, while building in efficiencies.

• Participate in the development of corporate positions on, and response to, proposed agency regulations and guidelines.

• Influence policy development and emerging regulations worldwide for device issues (internally and externally).

• Lead contributor to industry organization(s), effectively increasing Lilly's visibility and influence of evolving regulatory positions.

Leadership, Collaboration and Partnering

• Independently develop complex global regulatory strategies and networks for alignment across GRA- Drug Delivery and Digital Health, DDCS, product teams, and Manufacturing sites and affiliates, as required, to enable timely completion of product registration milestones.

• Take a proactive leadership role in the critical review of device specific development strategies and submission content.

• Create and effectively manage input deliverables into timelines for development of device/combination product registrations, resolving major issues and conflicts via networking directly with development teams, and GRA senior management.

• Proactively identify and resolve global device regulatory issues, leveraging internal experts to develop complex regulatory strategies. Frequently communicates risks to Regulatory pathways and submission reviews with potential mitigations and contingencies to reduce pre & post submission during reviews.

• Communicates effectively verbally and in writing to influence across GRA- Drug Delivery and Digital Health, and the Business Unit at the peer and management levels.

• Participate and leads forums that share regulatory information across GRA components.

• Lead preparation, review, and finalization of device documents for global CTA and registration submissions and response to questions.

Minimum Qualification Requirements:

• Bachelor's Degree in sciences, health or engineering discipline (e.g., biomedical engineering, engineering, pharmacology, chemistry, biology, biochemistry, pharmacy, or related scientific discipline)
• 7 years Pharmaceutical industry experience in technical drug development and/or medical device
• 7 years Regulatory experience with knowledge of combination products.

Other Information/Additional Preferences:

• Prior experience authoring submission content incorporating complex regulatory strategies.

• Demonstrated leadership, negotiation, and influence skills

• Demonstrated attention to detail

• Demonstrates passion for developing Regulatory skills and capabilities in others

• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

• Demonstrated strong written, spoken and presentation communication skills

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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