Regulatory Affairs Associate

2 weeks ago

Burlington, Canada Boehringer Ingelheim Full time

**Regulatory Affairs Associate**
**-**
**234817**

**OUR COMPANY**

**THE POSITION**

For projects assigned by the Manager, Regulatory Affairs, independently prepares, reviews and files high quality regulatory animal health product pre
- and postapproval submissions and ensures product compliance through proactive interactions with Canadian/international BI personnel as well as the Canadian Authorities. Consults with management, business units and other functional areas with respect to Canadian licensing options and time lines. Supports QA Department on regulatory assessment of QA-related issues.

**Responsibilities**
- 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).
- Ensures entry and quality of product documentation for Canadian AH products in corporate validated systems.
- 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.
- Supports QA for various needs identified by the QA team.
- Supports global manufacturing group in the assessment of proposed Change Controls.
- Adheres to all comprehensive BICL and Global, Animal health compliance requirements.

**Requirements**:

- Bachelor’s Degree (Biochemistry, Biology, Biopharmaceuticals, Chemistry, Medicine, Pharmacology, Veterinary Medicine)
- 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.
- 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).
- Strong attention to detail and follow-up, excellent organizational, time management, interpersonal, written and oral communication skills.
- Good data analysis capacity.
- Ability to work independently as well as to collaborate effectively with team members locally and globally.
- Excellent interpersonal skills with ability to work harmoniously with diverse teams (cross-functional collaboration).
- Multitask in a fast paced, changing environment.
- Ability to influence without authority.
- Agility, Accountability, Intrapreneurship.
- Strong communication skills.
- Internal networking ability.
- Ability to change and innovate.
- Basic knowledge of medical terminology.
- Fluent in English; knowledge of French an asset.

**WHY BOEHRINGER INGELHEIM?**

With us, you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.

We also offer a competitive salary, generous amount of paid time off (vacation, personal days, contingency paid time off for Long Term Contract Employees), comprehensive and flexible benefits plan, Defined Contribution Pension Plan with company matching of RRSPs, and Employee and Family Assistance Plan, employee and leadership development programs, and programs to support overall health and wellness for employees.

At Boehringer Ingelheim we embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.

**READY TO APPLY?**

BI Canada is committed to providing accommodations for people with disabilities to support their participation in all aspects of the recruitment and selection process. If you require accommodation, we will work with you to meet your needs.

**BI Canada COVID-19 Protocol**: BI Canada is strongly committed to providing a safe work environment for employees. We understand the need to enable safe in-person interactions whether at the office, external venues or customer locations. To do this, we need to ensure workplace interactions take place in a low risk environment.

At BI Canada we have introduced a COVID protocol. As of the time of this posting, this protocol requires new and existing employees complete

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