Regulatory Associate, Development Centre (req 134 and 135)

October 10 2019
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Scientific and Regulatory affairs, Pharmacology, Pharmacokinetics, Pharma, Biotech, Sciences, R&D
Boucherville, QC

Title: Regulatory Associate, Development Centre                         

Posting date: 2019-10-08

Work Shift: Day                                    

# Requisition: 134 & 135

Type of position: Full time

Type of employment: One permanent position and one temporary position for 18 months

Located in Boucherville, Avara Boucherville Pharmaceutical Services Inc. owns one of the largest sterile pharmaceutical factory in the country. Our mission is to become a world leader and offer a superior customer experience in the development and the manufacturing of pharmaceutical products. If you are recognized for excellence, quality, teamwork, and customer orientation: join our team!

We are presently seeking 2 Regulatory Associates for our Regulatory Development Center; one for a full-time position and another for an 18-month mandate.

Reporting to the Manager, Regulatory Development Center, the incumbent will be responsible for the preparation and deliveryof regulatory dossiers.  This includes regulatory submissions and responses to deficiency letters. The objective is to obtain regulatory approvals within an appropriate time frame in order to diversify the company's product portfolio.

Summary of tasks:

  • Prepare, review and organize necessary modules in order to complete regulatory files.
  • Define regulatory strategies and ensures these strategies meet regulatory requirements during their evolution.
  • Ensures reporting of the key performance indicators associated with the position's activities.
  • Maintain database in relations to regulatory activities.
  • Identify and negotiate regulatory requirements with teams and authorities.
  • Provide solutions when certain cases fall outside the usual regulatory frame.
  • Provide guidance to project teams when required.

 

Minimum requirements:

  • Bachelors' Degree in Science.
  • DESS in Pharmaceutical Development with a concentration in Regulatory Affairs (a strong asset).
  • Minimum two (2) years' experience in Regulatory Affairs, including writing of Module 3 as per eCTD and PDF publishing format requirements.
  • Ability to interpret various requirements from several regulatory authorities from around the world.
  • Excellent interpersonal skills, autonomy and good sense of priorities.
  • Excellent in French and English, spoken and written.

To apply for this position, please send your resume via this website with the requisition number and the title of the position in the subject of your email.

You may also visit our Careers Section via this web link:  https://macarrierepharmaceutique.com/#offres-demploi

Avara Boucherville is an equal opportunity employer and encourages diversity in its work force.

Only candidates retained for an interview will be contacted.

Apply now!

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