Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialized clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.Job Description
We are looking for a Regulatory Affairs Manager with excellent research, writing, and communication skills to work on NDS, OTC Drug & NHP Submissions. This is a senior role in a fast-paced environment where punctuality and professionalism are essential. It is a full-time position for a 1 year contract.
The successful candidate will be responsible for:
- NDS and OTC Drug Submissions in Canada and the USA
- NHP, Medical Device Submissions and Cosmetic Notifications
- Label reviews for Drugs, NHPs, Medical Devices, Consumer Products/ Cosmetics, and Food
- Cannabis applications and regulatory support
- Preparation of PSUR & PBRER reports
Requirements for the Regulatory Affairs Manager:
- Compile, complete & execute high quality regulatory drug submissions NDS/ANDS/SANDS/SNDS and monographed as per eCTD for Health Canada & FDA
- Prepare required documentation to support product and site/establishment licence applications (labels, efficacy & safety report, finished product specifications, quality summary report as required for NHPs, and medical devices
- Preparation of the Application to become a Licenced Producer/Grower under the Cannabis Act and Regulations and Quality Assurance System (including Quality Assurance Pre-licensing Report and Standard Operating procedures) to fulfill regulatory requirements for cannabis
- Liaise and negotiate with regulatory authorities to ensure scientific information is being disseminated as appropriate
- Assess international drug products dossiers, identify gaps to meet local requirements and prepare gap analysis
- Evaluate and file lifecycle management submissions (Notifiable Changes, Amendments and Annual Notifications of chemistry, manufacturing, and labelling updates).
- Compile Module 3 Quality & manufacturing documents to ensure successful approval - QOS and CPID
- Coordination and efficient communication with client and Health Canada or FDA to process Clarification Requests for Regulatory Drug Submissions.
- Prepare registration documents for the Provincial Formularies, Federal and Territorial drug plans, and Third Party payer plans according to their respective guidelines
- Manage all aspects of product label content development and marketing material
- Ability to search Pub Med and other on-line databases with comfort, and summarize literature
- Lead a small team of regulatory professionals
- All other tasks as required by the Company.
- A Bachelor degree or higherin a life science (Biology, Chemistry, Microbiology, etc.)
- Knowledgeable of Health Canada and FDA policies and guidelines to ensure regulatory approval of new drug submissions
- Proficient and comfortable working with electronic systems and with eCTD format, Word, Excel, PowerPoint
- An excellent ability to write clearly and concisely
- The ability to interact with staff, clients and regulatory officials in a positive and professional manner.
- A high degree of organization and attention to detail
- Excellent time management skills
- A team-oriented outlook with the capacity to work independently
- Able to travel throughout Canada and the U.S., as well as internationally as needed.
- Flexibility to visit client sites around Ontario as required to a degree normally associated with vehicle ownership;abstract may be requested.
What we offer:
- Excellent full time benefits including comprehensive medical, dental, and visioncoverage
- Life and disability insurance
- RRSP/DPSP eligibility with company match
- Paid vacation and holidays
- Employee Assistance Plan, Tuition Program and much more!
- This position will be working in an office environment within a laboratory facility,sitting at a desk working on a computer; occasional travel to client sites will be required. Light-intermediate lifting requirements of no more than 30 lbs. Hazardous materials are handled using established safety procedures and appropriate PPE.
- Extra hours may be required, as well as working periodic weekends and/or evenings.
Eurofins supports equal opportunities for inclusion and invites all qualified applicants within a commutable distance of North York, Ontario to apply; if accommodations are required in the application or interview process, please contact us via www.eurofins.ca. Only shortlisted candidates will be contacted - no phonecalls or emails please! Selected candidates can expect to be contacted in 3-6 weeks.
No agencies please!