Associate, Regulatory Compliance

at  Sandoz

Boucherville, QC, Canada -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate27 Nov, 2024Not Specified01 Sep, 20241 year(s) or aboveEnglish,Regulatory Requirements,Biochemistry,Preparation,Analytical Skills,Chemistry,Regulatory Affairs,Regulatory Documentation,Pharmaceutical IndustryNoNo
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Description:

As an Associate, Regulatory Compliance and part of a high-performing and inclusive team of regulatory experts, you will work on exciting projects that deliver affordable, quality medicines to patients every day.

ESSENTIAL REQUIREMENTS:

  • B.Sc. in Pharmacy, Chemistry, Biochemistry, or related field.
  • 3 to 5 years of experience in Regulatory Affairs, preferably in pharmaceutical industry.
  • 3 to 5 years of experience with Health Canada including at least 1 year experience with preparation and submission of regulatory documentation for Canada.
  • Basic Knowledge of Canadian regulatory requirements.
  • Comfortable with MS Suite Office and eCTD.
  • Fluency in oral and written French is mandatory. Due to the nature of our operations, oral and written fluency in English is required for regular communication with customers, partners, and/or colleagues, whether in Canada or internationally.
  • Skillful to manage / coordinate several projects simultaneously.
  • Ability to work independently and collaborate with cross-functional teams.
  • Very detailed oriented, strong analytical skills, able to make links and to propose solutions.

DESIRABLE REQUIREMENTS:

  • Knowledge of FDA, EMA requirements.
  • DESS in drugs development.
  • RAC certification.
  • Knowledge of Docubridge.

Responsibilities:

Your responsibilities include, but not limited to:

  • Gather and review all required documents for preparation of Module 1 for Canadian submissions, including labelling components.
  • Review Modules 2, 3, 4 and 5 provided by development centers to ensure that format and content are in adherence with Canadian requirements.
  • Manage deficiency letters, prepare response templates, respond to administrative deficiencies, review technical responses, prepare final compilation of response and confirm timelines.
  • Ensures compliance with regulatory databases and maintain awareness of relevant Canadian regulations and guidelines.
  • Able to discuss and collaborate with Health Canada on product specific challenges.

What you’ll bring to the role :

REQUIREMENT SUMMARY

Min:1.0Max:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

BSc

Proficient

1

Boucherville, QC, Canada