About the Company
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47 million people across the globe. Driven by innovation and a commitment to solving unmet medical needs, we are dedicated to advancing our robust pipeline and improving patient outcomes worldwide. Join a company where you can make a real difference in the lives of others.
Job Description
We are seeking an experienced and highly motivated Regulatory Affairs Manager with expertise in the pharmaceutical/medical device sector to join our dynamic team. This role is crucial for ensuring the timely and compliant development, registration, and lifecycle management of our innovative products across various international markets. The successful candidate will lead regulatory strategies, manage submissions, and ensure adherence to global regulatory requirements, playing a pivotal role in bringing critical therapies to patients worldwide. This position offers international sponsorship for qualified candidates.
Key Responsibilities
- Develop and execute comprehensive global regulatory strategies for pharmaceutical and/or medical device products.
- Prepare, review, and submit high-quality regulatory dossiers (e.g., INDs, NDAs, BLAs, MAAs, CE Mark, 510(k)) to health authorities globally.
- Serve as the primary liaison with regulatory agencies for assigned projects, leading interactions and negotiations.
- Interpret and communicate regulatory requirements and changes to cross-functional teams, ensuring compliance throughout the product lifecycle.
- Manage and mentor junior regulatory staff and/or project teams, fostering a collaborative and high-performance environment.
- Participate in product development teams, providing strategic regulatory guidance from early development through commercialization.
- Conduct regulatory intelligence activities to monitor evolving global regulations and assess their impact on company products and processes.
- Ensure all regulatory activities comply with internal standard operating procedures (SOPs) and external regulations.
Required Skills
- Minimum of 5 years of progressive experience in Regulatory Affairs within the pharmaceutical, biotechnology, or medical device industry.
- Demonstrated expertise in global regulatory requirements (e.g., FDA, EMA, Health Canada, PMDA, MHRA, TGA).
- Proven track record of successful regulatory submissions and approvals (e.g., INDs/CTAs, NDAs/MAAs, 510(k)s/CE Marks).
- Strong understanding of product development processes and regulatory science.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly.
- Strong project management and organizational skills, with the ability to manage multiple priorities in a fast-paced environment.
- Ability to work independently and collaboratively in a cross-functional team setting.
- Bachelor’s degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology, Biomedical Engineering).
Preferred Qualifications
- Advanced degree (Master's, Pharm.D., Ph.D.) in Regulatory Affairs or a related scientific field.
- Experience with international regulatory affairs beyond North America and Europe.
- Prior experience managing direct reports or leading significant regulatory projects.
- Familiarity with eCTD publishing software and electronic submission processes.
- Specialized experience in specific therapeutic areas (e.g., Oncology, Neuroscience, Immunology).
Perks & Benefits
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement savings plan with company match.
- Generous paid time off (vacation, sick leave, holidays).
- Performance-based bonuses and equity opportunities.
- Relocation assistance and international sponsorship support.
- Opportunities for professional development, training, and career advancement.
- Employee assistance program and wellness initiatives.
- On-site fitness centers and employee dining options where applicable.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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