Associate Manager - CMC Regulatory

Elanco; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Elanco seeks an Associate Manager, CMC Regulatory in Bengaluru, India to lead regulatory strategy and submissions for animal-health products across geographies. You will collaborate with manufacturing, quality and R&D to ensure lifecycle management and compliant submissions.

This role requires strong knowledge of FDA/CVM, EMA and VICH guidelines and the ability to mentor junior team members. The position offers a challenging, global remit with opportunities to influence regulatory outcomes and

Qualifications

• Degree in Science with 5+ years in Global Regulatory Affairs.
• Strong knowledge of FDA/CVM, EMA and VICH guidelines.
• Experience with CMC registrations in US/Europe/Rest of World.
• Ability to manage multiple pharmaceutical dosage forms and regulatory submissions.
• Excellent communication and organizational skills.

Responsibilities

• Lead CMC submission preparation for multiple geographies.
• Develop regulatory strategy for marketed products.
• Collaborate with R&D, Quality, Manufacturing and regulatory teams.
• Maintain documentation and timelines for global submissions.
• Provide trainings and mentorship to CMC team members.

Skills

Regulatory strategy

Cross-functional collaboration

CMC knowledge

Documentation

Communication skills

Education

Degree in Science (MSc, B. Pharm/M.Pharm, Postgraduate in Vet Sciences etc.)

Tools

Regulatory Information Management Tools

Job description

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today!

Your Role: Associate Manager - CMC Regulatory

The purpose of Associate Manager, 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.

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 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

What You Need to Succeed (minimum qualifications):

Degree in Science (MSc, B. Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,) 5+ 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

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.