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Regulatory Affairs Associate Jobs
Company | Boehringer Ingelheim |
Address | Burlington, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-05-21 |
Posted at | 1 year ago |
Our Company
- Work closely with the marketing departments and the business units to support business needs by establishing priorities and plan submissions, address gaps and exchanging information on regulatory dossier pathway to approval, as well as identifying possible regulatory-compliant solutions to issues.- Supports QA Department and in preparing and leading BICL AH participation in quality inspections from regulatory agencies and from Corporate and supporting the CAPA plans developed and implemented following observations.
- Ensures entry and quality of product documentation for Canadian AH products in corporate validated systems.
- Supports QA for various needs identified by the QA team.
- Proactively develops action plans and implements all activities, to achieve the timely and efficient registration of high quality submissions (market authorizations and post-market variations) for all assigned BI veterinary products within timelines prioritized and specified by the Canadian Animal Health Management Team and Regulatory Affairs Manager. Leads interactions between Canadian/international BI personnel and the Canadian Animal Health Authorities (CFIA & VDD).
- Adheres to all comprehensive BICL and Global, Animal health compliance requirements.
- Supports global manufacturing group in the assessment of proposed Change Controls.
- Fluent in English; knowledge of French an asset.
- Excellent interpersonal skills with ability to work harmoniously with diverse teams (cross-functional collaboration).
- Agility, Accountability, Intrapreneurship.
- Strong communication skills.
- Excellent Project Management skills, i.e. superior organizational, written and oral communication skills, the ability to work independently as well as to collaborate effectively with team members locally and internationally to meet strict deadlines.
- Good data analysis capacity.
- Ability to change and innovate.
- Thorough knowledge and understanding of Canadian regulations/guidelines concerning development, manufacturing and distribution of pharmaceutical, veterinary health products and biological products (GMPs, Food and Drug Regulations & CFIA regulations).
- Multitask in a fast paced, changing environment.
- Ability to influence without authority.
- Strong attention to detail and follow-up, excellent organizational, time management, interpersonal, written and oral communication skills.
- Ability to work independently as well as to collaborate effectively with team members locally and globally.
- Good working knowledge of business office software applications including Microsoft Office Word, Excel, PowerPoint and capacity to be trained to use specialized databases.
- Bachelor’s Degree (Biochemistry, Biology, Biopharmaceuticals, Chemistry, Medicine, Pharmacology, Veterinary Medicine)
- Basic knowledge of medical terminology.
- Internal networking ability.
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