- Responsible for managing multiple regulatory submission types across assigned molecules.
- Prepare regulatory submission related ancillary documentation as per appropriate regional submission requirements and route for timely review and approval.
- Create different regulatory dossiers for Europe, the U.S., Canada or other supported worldwide markets. Dossiers are distributed to regulatory agencies and Lilly affiliate offices worldwide.
- Lead the development and maintenance of Core labelling documents and provide oversight of global implementation for drug and combination device products.
- Lead the development of United States (US) and Canada packaging and combination device patient labelling.
- Develop, plan and execute appropriate regulatory strategies and agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives, such as development, technical services /manufacturing science (TS/MS), and quality.
- Help manage submission content for Drug Substance and Drug Product, and to provide guidance on structure and content placement within CTD registration submissions and to provide assistance with submission related Ministry of Health responses or Lilly affiliate questions.
- Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments.
- Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies
- Ability to make quick decisions and utilize critical thinking skills.
- Bachelor's or Master's Degree in a scientific, engineering or health sciences discipline (e.g., pharmacy, chemistry, biology, analytical sciences or related scientific discipline).
- 3+ years' industry-related experience in regulatory affairs; quality assurance; manufacturing; drug substance and/or drug development.
- Knowledge of pharmaceutical drug development or industry-related experience preferred.
- Less experience would be considered with a PharmD or a PhD degree in a related field.
- Demonstrated ability to build professional relationships and collaborate effectively with peers and stakeholders.
- Regulatory experience. Knowledge of FDA; Health Canada or other regulatory governance bodies' procedures and practices and awareness of evolving regulatory reform initiatives.
- Ability to apply medicinal therapeutic area expertise.
- Strong organizational and project management skills, with the ability to prioritize effectively.
- Demonstrated ability to assess and manage risk in a highly regulated environment.
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Associate / Sr. Associate - Global Regulatory Affairs (CMC & Labelling) - Cork, Ireland - Lilly
Description
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 41,000 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 1,600 employees across 38 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
Eli Lilly Cork's Global Regulatory Affairs (GRA) department has experienced considerable expansion since the team was established in 2021. As we continue to create medicines that make life better for people around the world, we are expanding the GRA department adding a number of additional roles within the Chemistry Manufacturing and Control (CMC) and Labelling Regulatory teams.
Responsibilities:
Requirements:
Additional Preferences / Other Information:
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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