Regulatory Affairs Manager, Oncology

7 days ago

Mississauga, Canada GSK Full time

**Site Name**: Mississauga Milverton Drive

**Posted Date**: May 31 2024
**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
- Mentors and trains junior staff

**Qualifications Required**:

- 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
- 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

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. 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).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

**Important notice to Employment businesses/ Agencies

  • Regulatory Affairs Director

    3 weeks ago

    Mississauga, Canada AstraZeneca Full time

    At **AstraZeneca**, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within **Oncology...

  • Regulatory Affairs Manager, Oncology

    2 weeks ago

    Mississauga, Ontario, Canada GSK Full time

    Site Name: Mississauga Milverton DrivePosted Date: May 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...

  • Regulatory Affairs Manager, Oncology

    4 weeks ago

    Mississauga, Canada 837 GlaxoSmithKline Inc. Full time

    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,...

  • Regulatory Affairs Manager, Oncology

    4 weeks ago

    Mississauga, Canada GlaxoSmithKline Full time

    Site Name: Mississauga Milverton DrivePosted Date: May 31 2024Key Accountabilities/Responsibilities:Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization areaAccountable for a portfolio of products, specific in the Oncology therapy area, including the preparation, filing...

  • Regulatory Affairs Manager, Oncology

    4 weeks ago

    Mississauga, Canada GlaxoSmithKline Full time

    Site Name: Mississauga Milverton DrivePosted Date: May 31 2024Key Accountabilities/Responsibilities:Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization areaAccountable for a portfolio of products, specific in the Oncology therapy area, including the preparation, filing...

  • Regulatory Affairs Manager, Oncology

    2 weeks ago

    Mississauga, Ontario, Canada GlaxoSmithKline Full time

    Site Name: Mississauga Milverton DrivePosted Date: May Key Accountabilities/Responsibilities:Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization areaAccountable for a portfolio of products, specific in the Oncology therapy area, including the preparation, filing and...

  • Translational Regulatory Affairs Director

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...

  • Translational Regulatory Affairs Director

    1 week ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...

  • Translational Regulatory Affairs Director

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    At AstraZeneca, we foster a collaborative culture that promotes knowledge-sharing, encourages ambitious thinking, and drives innovation - providing our employees with the opportunity to collaborate across teams, functions, and locations worldwide.Our ways of working prioritize individualized flexibility, allowing employees to balance personal and...

  • Translational Regulatory Affairs Director

    3 weeks ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...

  • Translational Regulatory Affairs Director

    3 weeks ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...

  • Regulatory Affairs Project Manager

    4 weeks ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...

  • Regulatory Affairs Associate

    3 weeks ago

    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive **Posted Date**: Jun 12 2024 **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, including the preparation, filing and approval...

  • Product Manager, Oncology

    2 weeks ago

    Mississauga, Canada Ipsen Biopharmaceuticals Canada Inc. Full time

    Genericization, New Product launch and Growth Molecules. If these terms captured your attention, then I have the perfect Product Manager role for you. As our Oncology Product Manager, you will develop strategies and tactics for oncology products. Specific areas of focus include brand plan development and implementation, target customer identification and...

  • Product Manager, Oncology

    2 weeks ago

    Mississauga, Ontario, Canada Ipsen Biopharmaceuticals Canada Inc. Full time

    Genericization, New Product launch and Growth Molecules. If these terms captured your attention, then I have the perfect Product Manager role for you.As our Oncology Product Manager, you will develop strategies and tactics for oncology products. Specific areas of focus include brand plan development and implementation, target customer identification and...

  • Regulatory Affairs Associate

    2 weeks ago

    Mississauga, Ontario, Canada GSK Full time

    Site Name: Mississauga Milverton DrivePosted Date: Jun 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, including the preparation, filing and approval of regulatory submissions...

  • Regulatory Affairs Associate

    3 weeks ago

    Mississauga, Canada 837 GlaxoSmithKline Inc. Full time

    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, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc) to aggressive targets. ...

  • Director of Regulatory Affairs and Quality

    2 weeks ago

    Mississauga, Ontario, Canada GlaxoSmithKline Full time

    Site Name: Mississauga Milverton Drive Please note: this is a month contract Hybrid role from our Mississauga office. Responsible for the effective functioning of the internal control framework including elements such as training, written standards, management monitoring, risk and issues management and inspection/audit readiness Develops regulatory...

  • CMC Regulatory Affairs Associate Director

    3 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Would you like to apply your Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines for products in development? Then AstraZeneca might be the company for you! At AstraZeneca, we do this with the upmost integrity...

  • Regulatory Affairs Manager

    2 weeks ago

    Mississauga, Ontario, Canada Bayer Full time

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...