Manager - CMC Regulatory

Your Role: Manager - CMC Regulatory

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 CMC 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.

Your Responsibilities:

• 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.,

• 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 RD, 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

What You Need to Succeed (minimum qualifications):

• Degree in Science (MSc, B. Pharm/M. Pharm, Post graduate in Vet Sciences etc. , )

• 8+ years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management

What will give you a competitive edge (preferred qualifications):

• 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

• Understanding of the cGMP requirements

• Experience working with Regulatory Information Management Tools and Systems

Additional Information:

• Travel: 0%

• Location: India, Bangalore

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.