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New Beta Innovation Canada Limited

Senior Specialist/ Assistant Manager, Regulatory Affairs

Details
Full Time
Yesterday

ABOUT THE COMPANY

New Beta Innovation Canada Limited (NBI) is a preclinical stage life sciences organization in Burnaby, BC. Leveraging on our expertise in research and development, we are transforming drug discovery into clinical applications for unmet medical needs. We have ongoing collaborations with top universities worldwide on various research projects, with distinguished achievements in the areas of oncology, neurology, ischemic and hypoxic conditions.

Our state-of-the-art GMP manufacturing facilities and laboratories in Greater Vancouver are home to a growing team of professionals who are inspired to develop advanced life-saving hemoglobin-based therapeutics for the well-being of people.


POSITION OVERVIEW

Reporting to the Senior Manager, Regulatory Affairs, the incumbent will perform a variety of Regulatory Affairs related functions to contribute to the registration of NBI-CA products in the global market and to the establishment and maintenance of overall site GMP readiness. 

KEY RESPONSIBILITIES

  • Reviewing, writing, and compiling technical information for global regulatory submissions
  • Providing critical review and analysis of data from externally conducted studies 
  • Developing and maintaining an understanding of all electronic technical specifications and content requirements for regulatory filings in Canadian and US jurisdictions 
  • Performing external site audits, such as visiting clinical trial sites and reviewing procedures and the facility as required
  • Assisting in meeting annual reporting requirements for existing regulatory filings and site licenses  
  • Reviewing and editing department and facility SOPs, especially regarding regulatory compliance
  • Participating in facility operations and status update meetings (RA representative) 
  • Working closely with other technical departments to achieve deliverables relating to regulatory submissions and to overall site GMP readiness 
  • Assisting in estimating annual departmental budget
  • Perform other tasks as required

KNOWLEDGE, SKILLS AND ABILITIES

  • B.Sc. in Biology, Chemistry, or related field
  • Minimum of 8 years of relevant work experience in the pharmaceutical or medical device industry
  • RAC (Regulatory Affairs Certification) is preferred
  • Good understanding of GMP, GCP, and quality systems
  • Experience in writing and reviewing regulatory submissions in eCTD format
  • Understanding of .PDF bookmarking/hyperlinking, document modifiers, metadata, and study tagging files
  • Experience with electronic data management systems and publishing software preferred
  • Understanding of ICH Quality (Q), Safety (S), and select Multidisciplinary (M4) guidelines
  • Familiarity with cleanroom or vivarium procedures is preferred
  • Experience with nonclinical study execution/design and bioassay techniques is preferred
  • Understanding of oncology and or hematology related nonclinical studies is preferred
  • Proficiency in developing innovative and creative solutions
  • Excellent interpersonal skills, ability to work independently but also in a team environment
  • Proficient in MS Word/Excel/Project with good writing and English grammatical skills

WHY JOIN NBI?

The best reason is because of our wonderful people and great work environment. If you are looking for a career with meaning and purpose, it’s hard to beat working in life sciences. We provide an attractive compensation and benefits package which recognizes people for their contributions, and comprehensive training and career development opportunities which support our employees’ growth with the company.

If you are interested in joining our team, we encourage you to APPLY today!

Category
Biotechnology

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About New Beta Innovation Canada Limited

New B Innovation (NBI) is a dedicated player in the global biotechnology market with a vision to advance life sciences and health care using the latest technologies and innovative approaches to del...

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Industry
Technology
Size
51-200 employees