Senior Regulatory Affairs Manager
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: Senior Regulatory Affairs Manager
As the Senior Regulatory Affairs Manager, you will be responsible for leading registration projects and regulatory activities to ensure compliance with local laws, regulations, and Elanco’s internal policies and SOPs.
This includes managing product registrations, license renewals, product variations, and marketing authorization transfers, while also supporting regulatory strategy and cross-functional collaboration to ensure product availability and compliance.
Your Responsibilities:
* Lead the development and execution of regulatory strategies and coordinate resources for timely, high-quality submissions.
* Prepare and deliver regulatory submissions for new product registrations, renewals, and variations.
* Coordinate with internal Elanco systems (e.g., Vault RIM, BLUE, Vault Clinical) to support registration processes.
* Liaise with regulatory authorities on product registration activities, inquiries, and reviews, including sample testing.
* Monitor and report adverse events (AE) and product complaints (PC) in compliance with Elanco SOPs and local/global regulatory requirements.
* Maintain accurate and up-to-date regulatory and legal documentation (licenses, certificates, etc.).
* Provide local regulatory expertise and scientific input to support global product development and R&D teams.
* Collaborate with cross-functional teams (Quality, Supply Chain, and Regional Support) to minimize regulatory-related supply disruptions.
* Review and approve promotional materials for regulatory compliance (Vault PromoMats).
* Support Quality Affairs projects and ensure alignment with regulatory requirements (Vault Quality).
* Participate in government affairs initiatives (e.g., CODEX, AMR policy) and key regulatory authority meetings to support affiliate strategy and compliance.
* Contribute regulatory insights to affiliate strategy, policies, and market access initiatives.
* Coordinate local development and post-marketing studies where applicable.
* Ensure full compliance with Elanco’s Code of Conduc...
- Rate: 730800000
- Location: Jakarta, ID-JK
- Type: Permanent
- Industry: Management
- Recruiter: Elanco
- Contact: Not Specified
- Email: to view click here
- Reference: R0023166
- Posted: 2025-10-11 08:47:18 -
- View all Jobs from Elanco
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