Job Title: Associate Manager – CMC Regulatory Writing
Job Location: Bangalore
Job 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 also executes 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 person 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:
- 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
- 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 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
Qualifications we seek in you for Manager – Regulatory Writing at Elanco !
- Degree in Science (MSc, B. Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,)
Minimum Experience:
7+ 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
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
Possible interview questions may be asked for Manager – Regulatory Writing at Elanco
1. Can you describe your experience in developing CMC (Chemistry, Manufacturing, and Controls) regulatory strategies for post-approval manufacturing changes?
Answer: In my previous role, I have been extensively involved in designing and developing CMC regulatory strategies for post-approval manufacturing changes for veterinary drugs. This includes ensuring regulatory compliance while maximizing business benefits and maintaining positive collaborations with internal R&D, quality, and manufacturing teams.
2. How do you stay updated with the applicable US FDA/CVM, EMA, and VICH guidelines?
Answer: I stay updated with the latest regulatory guidelines and requirements through continuous monitoring of regulatory agency updates, attending industry conferences, and participating in relevant training programs. This ensures that I am well-informed and able to apply the most current regulations to CMC submission activities.
3. Can you provide an example of a challenging CMC submission activity you managed for a global project?
Answer: In a recent global project, we had to submit a CMC variation for a veterinary drug in multiple regions with different regulatory requirements. Coordinating the submission activities across these regions while ensuring compliance with each region’s guidelines was challenging. However, through effective communication and meticulous planning, we successfully executed the submission within the required timelines.
4. How do you prioritize and handle multiple projects at different phases of development simultaneously?
Answer: Prioritizing and handling multiple projects requires effective time management and organization skills. I create a detailed project schedule, identify critical milestones, and allocate resources accordingly. Regular monitoring and clear communication with stakeholders help me ensure that each project progresses smoothly and meets its deadlines.
5. How do you approach decision-making when faced with complex situations that do not have a clear right or wrong answer?
Answer: In complex situations, I gather relevant data and seek input from subject matter experts. I analyze the available information and consider potential risks and benefits. I then collaborate with cross-functional teams to discuss and evaluate different options before making an informed decision that aligns with regulatory requirements and business objectives.
