Associate Regulatory Affairs

1 week ago


Mississauga, Ontario, Canada Dr. Reddy's Laboratories, Inc. Full time

Description

At Dr. Reddy's "Good Health Can't Wait"
By joining Dr.

Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives.

We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for _their_ community and _every_ community.


Diversity, Equity & Inclusion
***
Purpose:***The incumbent will ensure smooth operations of business in Canada including launch of new products, life cycle management for approved and marketed products, and DEL maintenance. Based in Toronto, Canada (Hybrid work schedule) this role will report to Lead Regulatory Affairs

Responsibilities:

  • Manage daytoday Canadian regulatory operations including timely filing, approval and launch of new products in Canada, with limited supervision
  • Provide regulatory oversight to life cycle management and continued support to ensure compliance for the marketed products
  • Maintain regulatory documentation
  • DEL maintenance
  • Labeling artwork review and compliance with regulations
  • PAAB submissions
  • Regulatory Intelligence
  • Assist the team lead with assigned work

Qualifications / Skills:

BS/MS degree in Pharmacy/Chemistry with at least 1-3 years of generic regulatory experience in pharmaceutical industry. Experience with US FDA / brand regulatory is a plus

  • Thorough understanding of regulations and guidance published by Health Canada
  • GMP & DEL requirements in Canada
  • Understanding of Pharmaceutical development and manufacturing processes; analytical, labeling clinical and nonclinical knowledge
  • Regulatory submission formats and filing categories
  • Strong oral and written communication skills
  • Strong organizational skills, attention to detail and flexible
  • Proven ability to anticipate challenges and negotiate through them to achieve desired outcome
  • Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously
Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.
***
COVID-19 Vaccination
***Getting vaccinated remains the most effective way to halt the spread of the COVID-19 pandemic, and Dr. Reddy's encourages all employees to be vaccinated. At this time, vaccinations are not mandated for Princeton-based employees but may become required in the future. Weekly COVID testing is mandatory for all employees who have not uploaded proof of vaccination or who are not fully vaccinated.

  • Equal Opportunity Employer:_
  • An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability._


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