Senior Associate Ii Regulatory Intelligence
il y a 1 semaine
locations- Zaventem- time type- Full time- posted on- Posted Today- job requisition id- JR00014663- Zoetis is currently looking for a Senior Associate Regulatory Intelligence.
- POSITION RESPONSIBILITIES:
- A Senior Associate on the Regulatory Intelligence Team will be responsible for supporting the management of global evolving regulations within Global Regulatory Affairs at Zoetis. This newly created position will work to help define this new function and identifying solutions and processes for aligning with key partners on implementation of new requirements and best practices.
- The incumbent will work collaboratively across all sites and relevant stakeholder functions to ensure evolving regulatory requirements expectations are known, communicated, and implemented across the network.
- You will work with internal and external experts including animal science partners, regulators, policy makers and other thought leaders in this space. In this role, you will provide regulatory policy intelligence and knowledge to internal teams, help drive the company’s advocacy agenda through engagement with key partners and assist in managing external relationships to advance regulatory policy.
- In addition, you may:
- Lead global surveillance activities by monitoring, identifying, and communicating up-to-date global regulatory dossier requirements to the broader Global Regulatory team which ensures regulatory compliance and facilitates registration, submission and post marketing of Zoetis’ products and services. In addition to dossier requirements, surveillance areas include, but are not limited to: compendial changes, chemical monitoring, pharmaceutical and non-pharmaceutical packaging, diagnostics, medical devices and inspectional GMP/Environmental activities.-
- Work with partner groups to identify sources of intel within the Global regulatory environment; determine which new or revised requirements should be assessed for impact.-
- Support the assessment of these new or changed requirements in collaboration with cross-functional representatives (Environmental Health and Safety, VMRD, Quality, Global Manufacturing, Public Affairs and Legal) and ensure that this assessment, as well as plans to bring processes and products into compliance, are well documented.-
- Coordinate and support state licensing activities for evolving regulations.-
- Support Zoetis’ sustainability goals.-
- Ensure timely notification and coordination of Zoetis responses to draft guidance, standards, consultations, and other external facing documents by working closely with SMEs.-
- Act as a representative for Zoetis in industry associations like AHI, Animal Health Europe, etc.-
- Coordinate any external consultant activities including managing feedback, review and approval of budget; acting as a liaison between Zoetis and the external consultant to ensure project goals are met.-
- Coordinate internal or customer inquiries related to changing regulations and guidance.-
- Develop experience interpreting Regulatory compliance trends, identifying and assessing risks, and action plans for Governance forums.-
- Develop a bias to think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.-
- Support the design and sustainability of overall Regulatory Intelligence processes for Zoetis Regulatory Affairs.- EDUCATION AND EXPERIENCE:
- Bachelor’s in a Scientific discipline with a minimum 3-5 years in Regulatory Intelligence or a Regulatory Liaison Role-
- Experience with Regulatory Intel systems preferred.-
- Ability to interact effectively with all levels of personnel within the organization. Must have the ability to lead and work within teams, including collaborating with colleagues, maintaining partnerships with other departments, serving on cross-functional teams, as well as cross divisional teams.-
- Reputation for superior customer service with excellent interpersonal skills-
- Desire and interest to leverage new technology and innovative information management tools-
- Outstanding communication skills (verbal and written).Demonstrated problem detection and problem resolution skills-
- Ability to take initiative and work independently with mínimal oversight-
- Excellent organization, prioritization, and time management skills - can work effectively under pressure-
- Must demonstrate integrity in all areas of the work environment; assess business and scientific ethics for all regulatory decisions and strategic plans.Good negotiating skills.- Other desirable attributes:
- Previous experience with management of evolving regulations as a member of industry associations (e.g. AHI, Animal Health Europe, EFPIA etc.)-
- An understanding of Animal Health product laws and regulations and the policy making process.-
- Experience with an animal health portfolio as the regulatory liaison working directly with Global Health Authorities-
- Experience with AI software.-
- Experience in development activ
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