Regulatory Affairs Manager
3 days ago
Education : EQUIVALENTEXPERIENCE
**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. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals, people, the planet and our enterprise.**
**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**
**Position Description**:
Responsible for providing overall accountability for registration projects assigned & regulatory activities, in compliance with local applicable laws, regulations, guidelines and Elanco’s policies and SOPs. Besides performing routine registration activities for new products, oversee and support market through GMP Clearance, renewal, product variations and Adverse Event/Drug Safety for all Elanco products; the incumbent will assist in the development of regulatory affairs strategy and action plan as well as regulatory affairs activities assigned.
**Functions, Duties, Tasks**:
- Under the general direction of supervisor, independently perform product registration.
- Compiling registration dossier and preparing other regulatory documents (e.g., local package label & insert, packaging components, and translating to local languages) and ensure timely regulatory submission upon internal review and approval.
- Provide technical expertise, local regulatory requirement understanding and sound scientific approach to global product development & R&D team.
- Responsible for the progress of the registration project. Coordinate with Elanco’s internal department (e.g. PCAP, BLUE, Vault RIM) in product registration process, including label creation.
- Communicate with regulatory agencies/institutes (FDA, DLD, Department of Medical science etc.) on product registration, including but not limited to regulatory inquiries, review committee meeting, sample testing, Adverse event reporting.
- Work effectively and flexibility within and across the affiliate, regional, and global team to achieve overall Elanco regulatory deliverables.
- Pharmacovigilance Reporting
- timely/closely monitor complaints/feedback from the field to ensure adverse events and product complaints reports submission as per Elanco
- SOP and global/local regulatory requirements.
- Input and properly maintain all regulatory and legal documentation.
- Knowledge of key laws, regulations and policies affecting Elanco’s business interests.
- Participates in meetings that drive affiliate’s strategy and outcomes.
- Collect internal and external regulatory and competitive information and report to the supervisor.
- Assist in Quality affairs project and procedures that are related to regulatory affairs.
- Assist in any other applicable regulatory tasks as assigned.
- Develop and review regulatory affairs SOP and other functional system.
- Coordinate the execution of local development and/or post-marketing studies when applied.
- Timely review and approve promotional materials and educational material to ensure regulatory compliance.
- Compliance with company rules and regulations including Ethics & Compliance and external laws and regulations.
**Minimum Qualification (education, experience and/or training, required certifications)**:
- Bachelor’s degree in pharmacy.
- At least 5-8 year experience in Veterinary Medicine/Pharmaceutical regulatory affairs
- Solid knowledge of local functional skills.
**Additional Preferences**:
- Strong communication skills in English (both written and spoken).
- Excellent interpersonal skills to handle sensitive and confidential information/ situation and able to network effectively across groups and levels.
- Good leadership and project management skills.
- Good team player.
- Ability to work under pressure and compliance with strict deadlines.
- Ability to prioritize or work with conflicting priorities.
- Advanced knowledge of MS Excel, Word, PowerPoint.
- Influence: Builds relationships and influences internal and external customers, Team player.
- Accountability: Accountable for Results, Good multiple-tasking focus, Strong follow through and closure of matter/case.
- Thinking capability: Analytical, Strategic, Creative, Good business judgment/knowledge
- Working Style: Persistence and Stability, Results Orientation, High learning agility, Proactive and fast response/having sense of urgency, Attention to details and adherence to guidelines.
- Values: Respect for Peo
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