Regulatory Affairs Strategist

6 days ago

Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

Job Description

About Us

We are 837 GlaxoSmithKline Inc., a global biopharma company dedicated to unifying science, technology, and talent to get ahead of disease together. Our mission is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.

We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Job Title: Regulatory Affairs Strategist - Canadian Market ExpertSalary:

$120,000 per year

Job Summary

We are seeking a highly skilled Regulatory Affairs Strategist to join our team in Canada. As a key member of our regulatory affairs department, you will be responsible for developing and implementing regulatory strategies for rapid approvals with optimal labeling for products within therapy or for submissions within specialization area.

You will ensure compliance with applicable Health Canada, industry, and GSK codes and guidelines in alignment with business needs. Your expertise will also be crucial in building trust with Health Canada contacts to improve GSK submission approval times, achieve competitive labeling, and resolve product-related issues impacting submissions, supply continuity, or compliance activities.

Responsibilities
  • Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area.
  • Accountable for a portfolio of products, including the preparation, filing, and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc) to aggressive targets.
  • Ensures compliance with applicable Health Canada, industry, and GSK codes and guidelines in alignment with business needs.
  • BUILDS TRUST WITH HEALTH CANADA CONTACTS TO IMPROVE GSK SUBMISSION APPROVAL TIMES, ACHIEVE COMPETITIVE LABELING AND RESOLVE PRODUCT-RELATED ISSUES IMPACTING SUBMISSIONS, SUPPLY CONTINUITY OR COMPLIANCE ACTIVITIES.
  • Communicates with and influences multiple local and global functions to achieve regulatory objectives.
  • Identifies and responds to issues related to assigned projects and/or products.
  • Interprets Canadian regulations, guidelines, and policies as they apply to GSK regulatory activities.
  • Mentors junior staff.
Requirements
  • B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
  • Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle
  • Must possess a thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines, and policies
  • Must possess a thorough understanding of drug development and commercialization process
  • Highly innovative (strategic and functional) and creative problem solver and decision maker who can apply continuous improvement techniques to gain efficiencies in submission preparation, product approval process, and resolving issues
  • Agile and able to effectively navigate change
  • Demonstrated ability to develop effective regulatory strategies aligned with commercial objectives
  • Working knowledge of global regulatory agencies and their practices
  • Excellent oral and written communication skills including the ability to present information and contribute ideas in small and large groups
  • Good influencing and relationship management skills
  • Excellent negotiation skills
  • Fully developed project management skills
  • Must act with integrity and demonstrate a strong and effective risk management perspective
  • Ability to provide and receive feedback, raise issues, share experiences, and lessons learned
  • Proactive and seeks to constantly learn and develop, ensures that skills meet changing business needs
  • Fosters strong team collaboration, with the ability to engage constructively with others and demonstrate a positive mindset. Open to diverse ideas, styles, and perspectives
  • Strong commitment to quality mindset
  • Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook
  • Canadian CMC Regulatory experience with small molecules, vaccines, and other biologics is an asset
Preferred Qualifications
  • Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.

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