Job Description

Regulatory Affairs Associate - 234817



OUR COMPANY
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 500 people across Canada. Learn more at www.boehringer-ingelheim.ca.


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\xe2\x80\x99s 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).
• Good working knowledge of business office software applications including Microsoft Office Word, Excel, PowerPoint and capacity to be trained to use specialized databases.
• 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.
Remote work options (if applicable for this role), will be addressed with candidates who are selected to participate in the interview process.
Want to learn more? Visit www.boehringer-ingelheim.ca


READY TO APPLY?
Visit https://careers.boehringer-ingelheim.com
Create an Account and log-in to apply on-line.
We thank all applicants for their interest in our company. Please note that only candidates selected for an interview will be contacted.
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 and submit an \xe2\x80\x9cEmployee Confirmation Statement re: \xe2\x80\x98Low Risk\xe2\x80\x99 Status\xe2\x80\x9d to Human Resources
For those employees who are fully vaccinated, they can on a voluntary basis provide the company with a copy of their vaccination certificate(s) through the Confirmation Statement.
For those employees who are not vaccinated, OR, have chosen not to share their vaccination status, they will be required to take the necessary steps to prove they have tested negative for COVID (through rapid tests that will be provided by the company) no more than 48 hours before they are in an in-person meeting or interaction. Employees will be required to take the COVID test and complete a form for BI, upload a picture of the test result and submit the form automatically. This form must be completed each time an employee takes the test before an in-person interaction with a customer, colleague, supplier etc.
The successful candidate for this Job Posting will be required to complete the mandatory Employee Confirmation Statement on the first day of employment with the Company.


DEADLINE FOR APPLICATIONS
Applications for this position will be accepted until May 5, 2023 (6pm EST)
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Emploi - R\xc3\xa9glementation/Conformit\xc3\xa9
Emplacement principal - Americas-CA-Ontario-Burlington
Organisation - CA-Boehringer Ingelheim Animal Health Canada Inc.
Horaire - Temps plein