Associate Manager – CMC Regulatory

Growth For Impact; Bengaluru; On-site; INR 1,800,000 - 3,600,000; Full time

Benefits offered by this job

Career development

Mentorship

Diverse environment

Training programs

Job summary

Growth For Impact in Bengaluru is seeking a seasoned Global Regulatory Affairs professional to design and lead CMC strategies for marketed products, balancing innovation with regulatory compliance. You will collaborate with R&D, Quality, Manufacturing and global regulatory partners, lead multi- geography submissions, and mentor the CMC team while staying current with global guidelines and trends.

This role emphasizes proactive communication, rigorous documentation, and timely delivery across

Qualifications

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

Responsibilities

• 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

Skills

Global Regulatory Affairs

CMC Life Cycle Mgmt

FDA/EMA/VICH guidelines

Regulatory submissions

Regulatory strategy

RIM tools

Communication skills

Decision making

Initiative

Tools

Regulatory Information Management Tools

Job description

ROLE

• 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

REQUIREMENTS

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

BENEFITS

• Opportunity to work with dynamic individuals
• Acquire new skills and experiences that will propel your career to new heights
• Part of a company that values and champions new ways of thinking
• Diverse and inclusive work environment
• Trainings and mentorship
• Career development opportunities