Associate, Established Products and Regulatory

2 days ago

Burlington, Canada Boehringer Ingelheim Full time

Associate, Established Products and Regulatory Operations-2212041

**OUR COMPANY**

**THE POSITION**

To plan, manage and coordinate the filing and approval of high quality regulatory submissions of established products to Health Canada and ensure product compliance through relevant regulatory registrations and interactions/negotiations with internal stakeholders and Health Canada.
Responsible for independently managing and performing the activities and interactions with the Central Service Unit (CSU) related to the compilation and archiving of high quality regulatory submissions in a timely manner for all BI Human Pharma products.

**Responsibilities**
- Plan and manage timely and efficient registration of high quality submissions of Established Human Pharma Products (post-market variations).
- Independently maintain submission publishing process standards and liaise with CSU (third party) to track compilation progress and review dossiers to ensure Health Canada regulations and guidelines are met.
- Provide business support for the workflow of regulatory submission documents through the document management system, including archiving.
- Foster operational excellence by keeping the department and Global Regulatory Operations team(s) informed on Health Canada eCTD/non-eCTD updates and ongoing Health Canada Pilot projects.
- Lead/user for many regulatory operations systems, identifying business and user requirements, testing and participating in the completion of appropriate systems documentation.
- Provide technical expertise in electronic information management and submission tools and strategies to assist other members of Regulatory Affairs and third party (CSU) during submission preparation and delivery.
- Maintain and administer in a timely manner the global regulatory information and documentation databases/systems to ensure all KPIs are met.

**Requirements**:

- Bachelor’s degree in life science and/or computer science or equivalent work experience in drug regulatory affairs in the pharmaceutical industry/health authority (2-5 years) is required. Certificate in Canadian Drug Regulatory Affairs from recognized institution is an asset.
- Sound knowledge of the Canadian Food and Drugs Act and Regulations, and Health Canada policies and guidelines.
- Thorough knowledge of eCTD/NeeS experience/understanding (experience with word processing and publishing tools).
- Strong attention to detail and solid excellent project management skills,
- Excellent planning, organizational and time management skills.
- Strong communication and negotiation skills.
- Ability to work independently or in a team environment, to complete work within strict deadlines.

**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 and submit an “Employee Confirmation Statement re: ‘Low Risk’ Status” 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

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