Associate, Regulatory Affairs

Job Description

As an Associate, Regulatory Affairs BD&L 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.

Your Key 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.
• Perform gap assessments of regulatory dossiers (Modules 2 and 3) and ensure that Health Canada regulatory requirements are met.
• Compile high quality product regulatory documents for new submissions and variations (ANDS/NDS and SANDS/SNDS) for various dosage forms to ensure timely approvals.
• Manage deficiency letters, prepare response templates, respond to administrative deficiencies, review technical responses, prepare final compilation of response and ensure timelines are met.
• 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.
  
  

Essential Requirements

What you’ll bring to the role:

• 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.
• Skillfull 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.
  
  

You’ll Receive

• A minimum of three weeks’ vacation.
• Paid time off in addition to your annual vacation and statutory holidays.
• Time back between Christmas and New Year’s Day with full pay.
• Generous and flexible group insurance coverage through our private plan.
• Employee and family assistance.
• Telemedicine services.
• Career enhancement and development, including learning, training and professional recognition opportunities.
  
  

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool

#Sandoz