Associate Manager - Regulatory CMC

Job Description:

Position Title: Associate Manager/Regulatory CMC Supervisor

Title: Associate Director Position

Type: Full Time

Job Function: Global Regulatory CM&C, Small Molecules

Location: Bangalore, Karnataka, India

Position Description:

- The purpose of Associate Manager, Global CMC Regulatory, is to work cross functionally with Elanco manufacturing and quality functions in support of executing regulatory strategy, oversee submission preparation and meet the reporting requirements for the maintenance of registrations of approved veterinary drugs (small molecules) with global regulatory agencies.

- This role may also execute CM&C operational support necessary to meet agreed upon timelines for the submission of supplements/variations, renewals, and annual reports for approved medicinal products.

- The candidate must have a strong knowledge of the applicable US FDA/CVM, EMA and VICH guidelines with the understanding of developing regulatory strategy for post-approval manufacturing changes for major geographical regions.

Functions, Duties, Tasks:

- Author high-quality CMC documentation for submission, applying CMC global regulatory strategies, assuring regulatory compliance.

- 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 and manufacturing.

- Maintain a positive business collaboration and partnership with global regulatory business partners of Elanco

- 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

- Lead and implement all global CMC submission activities for assigned projects/products, 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 accordingly.

- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions (US, EU and Rest of the World)

- Provide training and mentorship to CMC team members, as necessary.

Core Competencies:

- Strong knowledge of the applicable US FDA/CVM, EMA and VICH guidelines

- Experience with CMC registrations in the US and/or Europe

- 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 organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time

Minimum Qualification (education, experience and/or training, required certifications):

- Degree in Science / Postgraduate.

Minimum Experience: At least 5 years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management

Additional Preferences:

- Understanding of the cGMP requirements

- Experience working with Regulatory Information Management Tools and Systems