Manager - CMC Regulatory Writing
Location
Bangalore | India
Job description
As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
Position Description: The purpose of Manager, Global CMC Regulatory, is to work cross functionally with Elanco manufacturing and quality to develop regulatory strategy, oversee submission preparation and meet the reporting requirements for the maintenance of registrations/approvals of new animal drug with global regulatory agencies. These roles also execute CM&C regulatory functions necessary to provide supplements/variations, renewals, and annual reporting requirements for approved products. The person must have a strong knowledge of FDA/CVM and EMA guidelines with the understanding of developing regulatory strategy in the other major geographical regions.
Functions, Duties, Tasks: - Proven track record of overseeing end to end Life cycle management (LCM) of Small/Large Molecules/Complex dosage forms/Sterile preparations/Products derived from Biotechnology/Fermentation and Specialized dosage forms etc.,
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Note : end to end LCM involves Independently assessing Change Controls, Advising Business Partners with respect to Regulatory Impact of changes. Authoring/Reviewing/Compiling Regulatory submissions such as Post-approval variations for EU, Supplements/Annual Reports for USFDA etc.,)
- Design/develop CMC regulatory strategy for marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
- Maintain a positive collaboration and partnership with internal groups in R&D, Quality, Manufacturing and with global regulatory business partners of Elanco.
- Lead CMC submission preparation to provide high quality submissions to multiple geographies.
- Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams, while applying the global strategy into submissions.
- Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked according to the functional procedures.
- Author high-quality CMC documentation for submission, applying CMC global regulatory strategies, assuring regulatory compliance.
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
- Provide trainings and mentorship to CMC team members, as necessary
Core Competencies: - Strong knowledge of FDA/CVM, EMA and VICH guidelines
- Experience with CMC registrations in the US and/or Europe and/or Rest of the World
- Experience in managing multiple pharmaceutical dosage forms
- Strong communication skills, both written and oral
- Ability to make decisions when there is no clear right or wrong answer
- Self-starter, takes initiative
- Timeline driven
- Attention to detail
- Quality and customer focused mindset
- Strong organizational skills and an ability to handle multiple projects at different phases of development at the same time
Minimum Qualification (education, experience and/or training, required certifications): Advance Degree in Science (MSc, M.Pharm, Post graduate in Vet Sciences etc.,)
Minimum experience: 8+ years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management
Other Skills: Understanding of the cGMP requirements
Experience working with Regulatory Information Management Tools and Systems (e.g., Veeva)
Elanco is an EEO/Affirmative Action Employer and 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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