Regulatory Affairs Executive

3 days ago

Petaling Jaya, Malaysia Elanco Full time

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**:
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 potential manufacturing site change, marketing authorization transfer from legal regulatory owner to Elanco and maintain licenses in the markets through renewals and product variations 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**:

- Perform Regulatory Submission: product registration, renewal, and variation.
- Compile registration dossier and prepare other regulatory documents (e.g., local package inserts, packing components) and ensure timely regulatory submission upon internal review and approval.
- Coordinate with Elanco’s internal departments (e.g. Vault RIM, BLUE, Vault Clinical) in product registration process.
- Communicate with regulatory agencies/institutes (e.g., NPRA, DVS, Pesticide Board) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
- AE/PC- timely/ closely monitor complains/ 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 (Licenses, certificates etc.).
- Collaborate with cross-functions (Quality and Supply Chain and Regional Support Functions) to minimize supply disruption due to regulatory concern.
- Participate in association meetings that assist affiliate’s strategy and outcomes.
- Review and approve promotional materials through regulatory affairs aspects (Vault PromoMats).
- Knowledge of key laws, regulations and policies affecting Elanco’s regulatory interests.
- Assist in any other regulatory tasks as assigned.
- 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 veterinary medicine or pharmacy.
- At least 3-years’ experience in Veterinary Medicine/Pharmaceutical regulatory affairs in Malaysia - Solid knowledge of local functional skills.

**Additional Preferences**:

- Good communication skills in English (both written and spoken).
- Good interpersonal skills to handle sensitive and confidential information/ situation and able to network effectively across groups and levels.
- 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.

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

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