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Let's push the boundaries together and make the most of your talents!

Regulatory Affairs Manager, Canada

Location: 

Mississauga, Ontario, Canada

Job Function:  Regulatory Affairs
Job ID:  67379

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

 

The Manager, Regulatory Affairs is the Canadian lead on assigned investigational NCE/NBE and marketed products in the CNS and/or Immunology therapeutic areas. This role involves  following regulatory standards, providing risk/benefit analysis, advising on and implementing regulatory strategies and departmental policies, and utilizing resources consistent with the overall goals and objectives of the Regulatory Affairs department. The successful candidate will be accountable for the content, format and maintenance of assigned regulatory projects to expeditiously progress the development of investigational products toward eventual licensure, realize new market authorization approvals and maintain regulatory compliance for licensed products. 

 

You like to work in an environment where you can: 
•    Manage key regulatory development projects and marketed product changes to assure meeting company objectives;
•    Plan, track, compile and submit timely and complete documentation for regulatory dossiers which adhere to regulatory agency regulations, guidelines and expectations;
•    Interact with local and global cross-functional teams to develop sound regulatory strategy and execution plans.

You will contribute by: 
•    Critically evaluating relevant Canadian regulations and guidelines for their impact on new drug development activities and post-authorization changes, and advise the company appropriately;
•    Developing and implementing sound regulatory strategies to support assigned development projects and marketed product activities;
•    Producing clear, complete, concise and timely submissions to regulatory agencies;
•    Assuring that investigational/marketing authorization applications/post-marketing change submissions are in compliance with regulatory mandates and corporate goals and objectives;
•    Providing timely risk/benefit analyses of issues affecting company’s investigational and marketed products.

 

Interested? For this position, you’ll need the following education, experience and skills

 

Minimum Qualifications:

•    Minimum six (6) years Canadian pharmaceutical Regulatory Affairs industry experience.
•    In-depth knowledge of the drug development and CTA/NDS/post-marketing change processes, including associated regulations; 
•    Bachelor's degree in Science required; Master's degree preferred
•    Experience evaluating documents for submission to Health Canada;
•    Experience in assessing proposed CMC changes in light of the Post-NOC quality guidance;
•    Experience preparing NDS filings;
•    Experience preparing clinical and CMC post-approval submissions to Health Canada;
•    Proven ability in project leadership and representing the company in formal meetings, including presentations to and negotiations with Health Canada;
•    Experience with launch planning for new products and line extensions;  
•    Experience with promotional and medical material review and compliance with company and industry codes.

 

UCB Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

 

Why you should apply:

Do you want to contribute in bringing real value to patients living with severe diseases while driving innovation forward? 


Join UCB’s dynamic, inspiring and innovative environment. You will be recognized for impactful performance via a competitive compensation and benefits package and you will enjoy ample personal development opportunities.

 

Tell us what makes you the perfect match to our team and join our dynamic & forward-looking organizations. 


To apply, please go to www.ucb.com/careers.  
 

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

Apply now »