Regulatory Affairs Associate

8 hours ago

Laval, Canada Bausch Health Companies Full time

Join a team We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

**Job title**: Regulatory Affairs Associate (CMC)

**Location** :Bausch Health, Canada Inc. - Laval, Quebec (Hybrid, on site 3 days/wk)

**Type of position**: Contract, 12-18 months

**Key responsibilities**:

- Update of CPIDs and associated regulatory dossiers maintenance.
- Evaluation of change controls, determination of necessary requirements.
- Prepare and compile L3 submissions to Health Canada to maintain the conformity and life cycle of currently marketed products.
- Interact, communicate, and negotiate with internal and external stakeholders.
- Maintain current awareness of all Health Canada regulatory guidelines.

**Qualifications**:

- University Degree (B.Sc or masters degree) in Health Sciences. A DESS in Drug Development is also an asset.
- Minimum 1-2 years of relevant experience in Canadian Pharmaceutical Regulatory Affairs, with experience in managing drug products lifecycle and CMC data.
- Working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products (Division 1 and 8).
- Excellent organizational and communication skills (oral and written)
- Bilingual (English and French)
- Ability to prioritize and coordinate multiple tasks simultaneously and work with tight deadlines.
- Focus on customer needs; agility & flexibility; team player and respect of others.
- Computer Literacy Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat
- The masculine is used in this publication without prejudice for the sake of conciseness._
- Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates._

Bausch Health is an EEO/AA employer M/F/D/V.

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