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Associate Director - Global Regulatory Affairs, Regional Regulatory
Posted on Nov. 27, 2024
- Cork, Ireland
- 0 - 0 USD (yearly)
- Full Time
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 Eli Lilly Cork, 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 45,000 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse
People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
The Associate Director of Regional Regulatory Scientist provides direction, leadership, and technical/process expertise to the staff providing regulatory and scientific support for Lilly products at Cork GBS. The Associate Director in this position provides strategic input, focuses on the results, thinks critically and emphasizes and drives cross-functional team collaboration for achievement of Team Lilly goals and objectives. To achieve this goal, the GRA Associate Director uses their regulatory and submission expertise, a strong working knowledge of customers, internal procedures, guidances and regulatory precedence. The GRA Associate Director is responsible for recruitment, retention, resource assignment, staff development, and performance management. The GRA Associate Director is
accountable for completion of regulatory support activities and identification and implementation of process improvements.
1. People Management
- Recruit, develop, and retain a diverse and highly capable workforce.
- Ensure robust individual training plans and timely completion of required training for direct reports.
- Support and enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making.
- Remove barriers to ensure labelling and regulatory activities are completed accurately, timely, and in compliance with regulatory and quality system requirements.
- Actively coach and mentor staff, including providing strategic guidance to staff on regulatory and labeling process questions.
- Empower staff members to make logical decisions, resolve issues and execute tasks.
- Manage workload based on portfolio prioritization and address implications to overall resource management and strategies.
- Support and encourage a culture of innovation and model inclusivity to ensure diverse voices and ideas are heard and considered.
- Provide mentorship for the managers in the GRA team and across the site.
2. Regulatory Delivery
- Align regulatory/labeling strategy with molecule team priorities.
- Actively seek out information on the needs of internal and external customers and monitor US and Canadian regulations.
- Collaborate with business partners and management to evaluate and support priorities.
- Take a leadership role in the integration of work across the regulatory teams at the GBS sites.
- Demonstrate strong business acumen, problem-solving skills, and learning agility to help teams plan for contingencies, and adjust to change.
- Manage global cross-functional communication and issue escalations to ensure alignment on delivery and execution.
- Utilize regulatory and process knowledge to drive decision-making.
- Actively partner with upstream work units to ensure alignment and utilization of best practices.
- Partner with quality in both process improvements and deviation management.
- Monitor regulation/external environment as appropriate.
3. Facilitate Regulatory Processes
- Remove barriers to ensure regulatory activities are completed accurately, timely, and in compliance with regulatory and quality system requirements.
- Provide strategic guidance to staff on regulatory process questions.
- Monitor regulations and the external environment as appropriate.
- Provide technical, administrative and operational support for regulatory and labeling-related systems.
- Facilitate staff development to take a proactive approach in developing strategies in support of the molecule, while aligning with the GRA Regulatory team and management.
- Share regulatory knowledge with the team to establish trust and credibility.
4. Effective Management
- Model the innovation and leadership behaviours and regulatory excellence attributes as described in
- Participate in forums that share regulatory information across GRA components and other Lilly teams
- 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.
- Align resources based on portfolio prioritization and geographies.
- Ensure a compliance culture and state of inspection readiness.
- Model judgement-based decision making to navigate compliance and quality requirements.
- Proactively seek feedback on team’s performance for continuous learning.
- Participate as a member of the site leadership team.
Minimum Qualification Requirements:
- Bachelor’s Degree, preferably in a scientific or health-related field
- Demonstrated ability to communicate effectively (verbally and written) and to motivate and inspire others
- Supervisory experience
- Demonstrated flexibility and strong negotiation skills
- Previous experience, preferably 5 years in a lead role in the pharmaceutical industry
- Must understand regulatory processes and the interdependencies of various tasks that require coordination among cross-functional team members and possibly third parties
- Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
- Strong problem-solving skills: able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent reoccurrence
- Strong communication skills; able to communicate clearly and succinctly with team members and leadership
- Proven ability to coach and develop others
- Ability to embrace the diversity of thought to model innovative behaviors (e.g., reaching across boundaries, inspire and empower others and lead decisively in the midst of ambiguity)
Other Information/Additional Preferences:
- Ability to manage multiple projects/people
- Conflict management/conflict resolution skills
- Able to influence others without direct authority
- Effective interpersonal skills
- Travel may be required
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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