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.
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, embRACE, LGBTQ+ & Ally 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!
This is a 12-month FTC.
Purpose:
The purpose of the Manager, Sr. Manager, GRA Regional Regulatory, Affiliates Regulatory role is to manage all aspects of regulatory affairs for the marketing affiliate, including:
Supervise the Regulatory Affairs Department to ensure the success of new product registration, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements (whichever is more stringent).
Foster an environment of operational excellence through regulatory expertise and, if relevant, managing and developing direct reports and collaborating with cross-functional teams to successfully achieve Affiliate regulatory objectives.
Facilitate and cultivate external relationships with the relevant Government bodies and industry associations.
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 Strategy
Develop and Implement the Regulatory Plan and Strategy in alignment with affiliate business plans as well as regulatory requirements.
Ensure submission and approval of high-quality regulatory applications within planned timelines. Maintain clear metrics for Regulatory deliverables.
Preparation and support of new applications to obtain marketing authorizations.
Voicing affiliate perspective and needs to global and regional regulatory contacts.
Ensuring timely responses to requests from support groups and/or Regulatory Authorities.
Maintaining marketing authorizations (timely submission of post approval maintenance activities like renewals, variations and periodic reports)
Actively participate in the affiliate launch teams, anticipating and delivering regulatory outcomes to support the affiliate launch plan.
Represent the Regulatory Affairs function as appropriate in Affiliate Lead Team, New Product Planning discussions
Represent Lilly in external industry meetings.
Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally.
Interact directly or facilitate interactions with regulatory bodies on a regular basis as appropriate.
Regulatory Compliance
Ensure that internal Regulatory IT tools are up to date and accurate and actively use available tools to monitor regulatory plans.
Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.
Implement robust processes to keep regulatory archive complete and up-to-date and to ensure that all current licenses and labels are readily available.
Create, implement and maintain local quality system in line with the global quality system and local regulations.
Manage and support internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.
Lead and coordinate implementation of corrective/preventive actions as appropriate.
Lead regulatory quality oversight of Third Parties (i.e. Regulatory Services Providers, Translators, Graphic Agencies, etc.) as appropriate.
Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions.
Labelling
Perform the function of Primary, Alternate or Delegate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or MOH timelines.
Ensure adherence with global labelling procedures and document relevant exceptions in order to produce accurate and high-quality Product Information which is in compliance with global core labeling
Process Improvement
Identify local process improvement opportunities and ensure implementation of relevant global regulatory initiatives.
Consistently participate in affiliate cross-functional teams and provide regulatory status updates, input and knowledge.
Ensure alignment and implementation of launch readiness initiatives.
Facilitate and maintain relationships with key regulatory officials (External Influence).
Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives to improve and maintain understanding of regulatory affairs within affiliate leadership.
Personal and Professional Development
Knowledge and understanding of local regulations and local, regional and global regulatory procedures.
Create and maintain a positive and effective working environment and, if applicable, effectively lead, manage, motivate and mentor the Regulatory Affairs team and assist direct reports in extending their technical skills. Assure key talent retention, development, reward, and recognition.
Manage own performance and development by actively setting and meeting individual professional development goals.
Attend appropriate external symposia, workshops or conferences to develop and sustain an appropriate level of professional expertise
Optional Responsibilities: This section is intended to provide additional responsibilities the position may require depending on the Affiliate structure and/or local requirements. Consult with your supervision regarding these additional responsibilities in order to confirm which ones apply to this position. It may apply all or some of them.
Patient Safety
Assist the Affiliate Pharmacovigilance Responsible Person in reporting received Adverse Events and submitting expedited and periodic safety reports to the Agency/MoH as per local regulations.
Product Quality
Assist the Product Quality Representative with the implementation and execution of Lilly Global Quality Standards in particular GQS-181/CQP-181 in the affiliate. Identify and support Product Quality tasks and, in collaboration with the Product Quality Representative, act as the local Quality contact.
Support the Product Complaint system as local Responsible Complaint person.
Minimum Qualification Requirements:
Bachelor's degree or equivalent in a relevant scientific subject
At least one year industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needs.
Team working skills with special focus on results.
Ability to adapt to challenging situations.
Demonstrated good computer/IT skills.
Good knowledge of written and spoken English.
Other Information/Additional Preferences:
People management & leadership experience
First class communication skills.
Excellent planning and priority setting.
Strategic thinking.
Strong capability to establish positive networking both internally and externally.
Strong knowledge of quality systems.
Other Information/Additional Preferences:
Travel expected (less than 10%)
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.
#WeAreLillyUKandIreland