Regulatory Affairs Associate

5 months 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. 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, 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.

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 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.

#LI-GSK

#HYBRID

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

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.



  • Mississauga, Canada Amgen Full time

    Career Category Regulatory **Job Description**: HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is...


  • Mississauga, Canada Amgen Full time

    **HOW MIGHT YOU DEFY IMAGINATION?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...


  • Mississauga, Canada Mint Pharmaceuticals Inc. Full time

    Job description Canadian-owned and operated, Mint Pharmaceuticals Inc. ("Mint") is a leading manufacturer of high-quality and affordable generic pharmaceutical products. With a focus on consistent supply, innovation and exceptional customer service, Mint aims to deliver the highest value to patients across Canada. Mint has repeatedly been recognized as one...


  • 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...


  • Mississauga, Canada AstraZeneca Full time

    **Regulatory Affairs Associate** **Hybrid Work - on average 3 days/week from office** **Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees...


  • Mississauga, Canada Cliantha Research Ltd. Full time

    **Job Description / Roles and Responsibilities for Job Title**: **1)** Maintain an excellent knowledge of clinical trials/clinical research and a thorough understanding of industry regulatory requirements **2)** Stay current on regulatory updates and issue regular communications bulletins within the organization **4)** Communication with the regulatory...


  • Mississauga, Canada Ryvis Pharma Full time

    **The Regulatory Affairs Associate is responsible for planning, coordinating, compiling, submitting, obtaining approval, maintaining drug product registrations for Canada and the U.S. and assisting global drug product registrations.**: **Type**: 12-month Contract with an opportunity to convert to full-time based on performance. **Location**: Mississauga,...


  • Mississauga, Canada Boston Scientific Corporation Full time

    **Work mode**: **Onsite Location(s)**:Mississauga, ON, CA**Additional Locations**: Canada-ON-Mississauga; Canada-ON-Toronto**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing...


  • Mississauga, Canada Boston Scientific Corporation Full time

    **Posted Date**: - Sep 23, 2024**Workmode**: - Hybrid**Additional Locations**: Canada-ON-Mississauga; Canada-ON-Toronto **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing...


  • Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Regulatory Affairs ManagerJob SummaryThe Regulatory Affairs Manager provides leadership and support to the Regulatory Affairs department, ensuring compliance with industry regulations and government codes. This role involves reviewing and assessing emerging regulatory issues, industry standards, and government initiatives, and providing advice and guidance...


  • Mississauga, Canada The Portage Group Full time

    **Position Summary** Our client, the **Heating, Refrigeration and Air Conditioning Institute of Canada** (HRAI) is seeking a Director of Standards and Regulatory Affairs. This position will oversee HRAI’ s manufacturers division and execute HRAI’s standards and regulatory affairs work. The role will have a significant focus on harmonization with U.S. &...


  • Mississauga, Canada GE Healthcare Full time

    **Job Description Summary**: The Regulatory Affairs Intern will be involved in Premarket and Compliance duties. They will work with a team of Regulatory Affairs professionals and provide support to ensure GEHC establishes and implements best practice processes and procedures in premarket support. **Key responsibilities/essential functions include**: - **...


  • Mississauga, Ontario, Canada BAXTER Full time

    Key Responsibilities:- Prepare and submit regulatory documents, including NDS, SNDS, Medical Device Applications, and CTAs, according to current Health Canada requirements.- Collaborate with stakeholders to provide accurate and timely responses to Health Canada, identifying priorities and key issues in complex situations and achieving resolution with minimal...


  • Mississauga, Canada Cardinal Health Full time

    Cardinal Health Canada, with over 1300 employees nationwide, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country. Cardinal Health Canada is currently seeking a Regulatory Affairs Specialist to join the Regulatory Affairs and Quality Assurance team...


  • Mississauga, Ontario, Canada Juno Pharmaceuticals Full time

    Regulatory Affairs Project ManagerA Regulatory Project Manager at Juno Pharmaceuticals plays a crucial role in ensuring the successful growth and maintenance of the company's product portfolio. This position involves effectively preparing and managing assigned Regulatory Affairs projects to meet regulatory requirements and ensure compliance.Key...


  • Mississauga, Ontario, Canada Brenntag Specialities Full time

    At Brenntag Specialities, we are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mississauga. This role is responsible for providing support to the organization in maintaining compliance and addressing needs related to new and existing business as they pertain to regulatory matters.Key ResponsibilitiesManage risk considering legal...


  • Mississauga, Ontario, Canada Juno Pharmaceuticals Full time

    A challenging opportunity has arisen at Juno Pharmaceuticals for a Regulatory Affairs Project Lead to oversee the management and preparation of assigned projects. This role is critical in ensuring the successful growth and maintenance of our product portfolio in a fast-paced environment.Responsibilities:Independently manage Regulatory Affairs projects,...


  • Mississauga, Canada CT BAKERY Full time

    Job Overview* **Duties**: - Develop and implement regulatory strategies for product approvals - Monitor and interpret regulatory requirements and changes - Prepare and submit regulatory filings and documentation - Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle - Conduct regulatory research and...


  • Mississauga, Ontario, Canada https:www.energyjobline.comsitemap Full time

    Job Title: Director of Sustainability and Regulatory AffairsFood, Health & Consumer Products of Canada (FHCP) is seeking a highly skilled Director of Sustainability and Regulatory Affairs to join its sustainability team. The successful candidate will be responsible for leading the development and implementation of sustainability strategies and policies that...


  • Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Prepare and submit regulatory documents, including NDSs, SNDSs, CTAs, and NCs, to achieve aggressive targets.Build and maintain relationships with Health Canada contacts to improve submission approval times and achieve...