About this role
- Working a PAS for a new formulation of product;
- Phase 3 IND for a new product and some variations around facilities and filling and packaging suites.
- A minimum of 4 years in RA in the pharmaceutical industry is preferred;
- Experience with Biological products is preferred;
- Thorough knowledge of the Canadian, US, and European and guidelines/ policies regarding regulatory preparations/ submissions;
- Experience with ANDA, PAS submissions;
- Organization and time management skills;
- Strong computer skills, mainly in the use of Microsoft Office;
- Strong written and verbal communication skills;
- Interpersonal skills;
- Commitment to team work;
- Detail oriented;
- Experience with CTD format.
What we offer
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
- Publication: PUB231422
- Location: North York
- Market: LifeSciencesAndHealthCare
- Hours per week: 35
- Branche: Pharmaceutical
- Education level: AcademicBachelor
- Area of expertise: Regulatory
- Closing date: November 2, 2019
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