刊登日期: Apr 14 2025
Key Accountabilities/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, specific in the Oncology therapy area, 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 labelling and resolve product related issues impacting submissions, 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 and trains junior staff
Qualifications Required:
- B.Sc. in life science or relevant scientific field (e.g. pharmacology, medical oncology, toxicology, chemistry)
- Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle
- Experience with solid tumour and/or ADC targeted cancer therapeutics regulatory reviews.
- Experience with small molecule and biologics regulatory reviews.
- 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
Preferred Qualifications
- Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.
*LI-GSK
GSK 是致力於倡導多元化和包容性，實踐就業機會均等理念的雇主。我們歡迎所有合格人士應徵我們所提供的工作機會。GSK 致力於為殘疾人士提供無障礙設施。如果您在應徵過程的任何階段需要無障礙設施，或是想要取得我們的無障礙設施政策的詳細資訊，請透過以下電子郵件與我們連絡：canada-recruitment@gsk.com。請勿寄送履歷至此電子郵件，煩請透過此職缺的線上應徵程序應徵。
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