The purpose of the Senior Director/Executive Director, Regulatory Scientist role is to provide leadership and oversight to deliver Asia Pacific (AP) regulatory strategies and Win Through Regulatory for assigned assets. The Regulatory Scientist will have therapeutic area alignment and partner across Lilly teams, partner companies, and health authorities to enable market differentiation of first-in-class/best-in-class assets.
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.
1. Regulatory and Scientific Expertise
Develop, Update and Execute Asia-Pacific Registration Strategy
Initiate and Update Regulatory Strategy Document
- Initiate and update regulatory strategy documents by leveraging scientific, drug/device clinical development and knowledge from AP regulatory agency meetings and regulatory trends. Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies.
- Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by Lilly and knowledge of competitor labelling.
- Monitor upcoming and recent approvals of competitive development programs/plans
- Integrate AP regional regulatory strategy into global registration strategy
- Serve as global regulatory coordinator as assigned by GRA management.
- Partner with colleagues across regulatory functions, particularly the global regulatory lead of the assigned molecules, to deliver integrated AP regulatory strategy
- Communicate and share key information to enable seamless execution of AP regulatory strategy
Provide input to clinical program to support market differentiation needs
- Communicate the regulatory options and impact on proposed product development plans.
- Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation of first-in-class/best-in-class assets.
- Collaborate with Pricing Reimbursement and Access (PRA) and Value Evidence Outcome(VEO) for the success of the pricing and access strategies through influencing what data is needed and how it is collected on development or product lifecycle planning
Lead development and update of labeling strategy to deliver market differentiation
Initiate and update Claims Mapping and Labeling Dashboard
- Partner with regulatory, product and clinical development, commercial and project personnel to drive a Market Differentiation as Driver Strategy using available tools and resources (e.g. Claims mapping) and network for alignment. Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments. Use global labelling strategy to influence the drug development strategy, as needed.
- Create and communicate labeling dashboard to drive internal alignment on labeling strategy and key risks.
Partner with Affiliate GRA teams to develop and Update local labeling, including prescribing information, patient labeling, device labeling (IFU) for new products and indications
- Lead the development of the labelling strategy in collaboration with other regulatory and project personnel and network for alignment across affiliate labelling team to enable timely completion of regional product (drug and device) registration milestones (submission, approval and launch).
- Lead strategic development of regional labelling documents for initial submission, line extensions, key MOH-initiated changes, and key PMR-related updates, and provide responses to agency labelling questions. Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling.
- Lead and develop the strategy for submission and amendments for: IND, IDE, NDA/BLA, NDS, and de novo
- Determine and communicate submission and approval requirements and regulator expectations
- Generate regulatory documents for medium to high complexity submissions. Ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written to articulate Lilly’s scientific position.
- Anticipate, resolve, and communicate key technical, operational, and strategic issues that may impact other development functions or the development team.
- Propose innovative solutions to regulatory and labelling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems.
Primary liaison with product and clinical development team and liaison with diagnostic development experts
- Provide high quality, timely and decisive regulatory advice that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning and business development
- Communicate regulatory risks, potential impact and mitigation plans with development team leadership and regulatory management
- Cultivate relationships with development teams and leadership.
Liaison with global marketing/New Product Planning/Value Evidence Outcome/Payer functions/affiliate GRA/ Brand Teams
- Contribute to global and regional launch-readiness plan and connect commercial partners (global marketing/NPP/VEO/Payer functions/ Brand Teams) with development teams to drive market differentiation strategy for assigned assets, including labelling and promotional deliverables throughout the product lifecycle
- Cultivate relationships with global marketing/NPP/VEO/Payer functions/affiliate GRA Brand Teams and affiliate leadership.
Partner with Affiliate GRA on relationship and interaction strategy with regional regulatory authorities
- Build, maintain, and leverage relationships with AP regulatory agencies, team members, and partner companies as appropriate.
- Execute high quality communications with regulators and internal customers to articulate and ensure understanding of the regulatory strategy and complex issues.
- Accountable for communications to the regulator, development teams, and GRA, other development functions, Research, and BU leadership.
Engage in, influence, and shape external environment initiatives related to portfolio assets
- Create and foster strategic relationship with key external players to identify and anticipate opportunities for growth. This may include external regulatory agencies and experts, academic thought leaders, and industry groups.
2. Lead/Influence/Partner
- Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions
- Model the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
- Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners
- Constructively challenge teams to reach the best solutions to issues
- Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions
- Serve as a mentor for affiliate GRA-AP personnel and others in GRA
- May have direct reports.
Minimum Qualification Requirements:
- Advanced scientific degree (i.e., PhD, MD, PharmD) or bachelor’s with at least 5 years of relevant drug development experience
- Industry-related experience in regulatory affairs and/or drug development experience for 5 years
- Knowledge of AP regional regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable
- Deep knowledge of the drug development process
- Ability to assess and manage risk in a highly regulated environment
- Strong written, spoken and presentation communication in English. Chinese, Korean and Japanese language fluency desirable.
- Negotiation and influence skills
- Attention to detail
- Effective teamwork skills; able to adapt to diverse interpersonal styles
Location: Singapore
Other Information/Additional Preferences:
- Travel expected (20-25%)
