Elanco is indeed an American pharmaceutical company that specializes in producing medicines and vaccinations for pets and livestock. Prior to 2019, it was a subsidiary of Eli Lilly and Company, a well-known pharmaceutical corporation.
The post of Associate Manager – CMC Regulatory Writing at Elanco Animal Health Incorporated involves various responsibilities and tasks related to regulatory affairs for veterinary drugs (small molecules). Here’s a summary of the key functions, duties, and candidate requirements for this position:
Position Description: The Associate Manager, Global CMC Regulatory, is responsible for working cross-functionally with Elanco’s manufacturing and quality teams to support the execution of regulatory strategy, oversee submission preparation, and meet reporting requirements for maintaining registrations of approved veterinary drugs globally. The role involves providing operational support for the submission of supplements/variations, renewals, and annual reports for approved medicinal products. The individual must have a strong understanding of the US FDA/CVM, EMA, and VICH guidelines, enabling them to develop regulatory strategies for post-approval manufacturing changes in major geographical regions.
Functions, Duties, Tasks:
- Design and develop CMC regulatory strategies for marketed products with a focus on creativity, innovation, and balancing business benefits with regulatory compliance.
- Collaborate and partner with internal groups in R&D, quality, and manufacturing to maintain positive working relationships.
- Establish positive business collaborations and partnerships with global regulatory business partners of Elanco.
- Proactively communicate CMC regulatory strategy, key issues, and critical topics to interdisciplinary project teams throughout the life cycle.
- Lead and implement all global CMC submission activities for assigned projects/products, aligning with the global strategy.
- Ensure that required documentation, content, quality, and timelines for global submissions are communicated to appropriate teams and tracked accordingly.
- Author high-quality CMC documentation for submission, adhering to CMC global regulatory strategies and ensuring regulatory compliance.
- Stay updated with regulatory guidelines and requirements in all global regions and new technical trends.
- Provide training and mentorship to CMC team members as necessary.
- Strong knowledge of applicable US FDA/CVM, EMA, and VICH guidelines.
- Experience with CMC registrations in the US and/or Europe.
- Excellent written and oral communication skills.
- Ability to make decisions in situations with no clear right or wrong answers.
- Self-driven and proactive with a focus on meeting timelines.
- Detail-oriented with a customer-focused mindset.
- Strong organizational skills and ability to handle multiple projects at different phases of development simultaneously.
- Degree in Science (MSc, B.Pharm / M.Pharm, Postgraduate in Vet Sciences, etc.).
- At least 7 years of experience in Global Regulatory Affairs, preferably with a focus on Post-approval CMC Life Cycle Management.
- Understanding of cGMP requirements.
- Experience working with Regulatory Information Management Tools and Systems.
This role requires an individual with a strong background in regulatory affairs, particularly in the post-approval phase of CMC Life Cycle Management for veterinary drugs. It demands excellent communication, decision-making, and organizational skills, as well as the ability to handle multiple projects effectively. A solid understanding of global regulatory guidelines and requirements is essential for success in this position.
Position: Associate Manager – CMC Regulatory Writing
Experience: 7+ years
Qualification: MSc, B. Pharm/M.Pharm, Postgraduate in Veterinary Sciences, or related fields
Industry Type: Pharma
Functional Area: CMC Regulatory Writing
To apply for this job please visit elanco.wd5.myworkdayjobs.com.