Regulatory Affairs Specialist
The success of a company depends on the passionate people we partner with.
Together, let's share our talents.
As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.
We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.
Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.
As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.
Your
missions :
Regulatory Affairs Specialist
Responsibility to ensure that regulatory submissions and compliance are executed for all products in a given country or region. Develop and communicate with head office on the regulatory strategy and life cycle management of all products in the count. Helping to update company's database and archives.
Responsibilities:
Regulatory Plan/Execution
- Ensure logistics support for the local registration
Dossier Preparation/Compliance Check/Submission
- Collect, update and maintain appropriate scientific data and documentation needed to assess impact
- Ensure data collection and database updates and archive
- May assist Zone Manager
LOQ Answer/Submission/Interaction with Authority
- Collect, update technical and administrative documentation if required, and maintain appropriate scientific data and documentation needed to prepare variations and renewal dossiers and to ensure answers to list of questions in a timely manner
Maintenance and LCM
- Support Zone RA manager in assigned projects and related activities
- Helping to update the company’s database and achieve if necessary
Knowledge and Intelligence Management
- Collect and maintain regulatory requirements of countries
- Archive all submitted documents
- Maintain tools, databases and process
Competencies:
- Drive Ambition & Accountabilities
- Influence Others
- Collaborate with Empathy
- Engage & Develop
- Shape Solutions out of Complexity
- Client Focus
Qualifications:
- BS or BA in science field or relevant work experience required
- At least 2 years of experience in animal health or related industry is required
- Experience in regulatory or research and development is desirable
- Experience with CFIA regulations or business for biologics, preferred
- Strong written and verbal communication skills
- Excellent interpersonal and networking skills
- Ability to organize and prioritize multiple tasks
- Ability to work independently
- Decision making and attention to detail
Disclosures:
- This requisition is for a current opening at our Guelph, ON facility
- Targeted annual salary between $70-80k but may vary upon education, skills and experience
Your
profile :
Qualifications:
- BS or BA in science field or relevant work experience required
- At least 2 years of experience in animal health or related industry is required
- Experience in regulatory or research and development is desirable
- Experience with CFIA regulations or business for biologics, preferred
- Strong written and verbal communication skills
- Excellent interpersonal and networking skills
- Ability to organize and prioritize multiple tasks
- Ability to work independently
- Decision making and attention to detail
