Regulatory Affairs Associate

3 weeks ago

Mississauga ON, 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 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 and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Summary:

You will assist other members of Regulatory Affairs Management (RAA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and AstraZeneca standards.

Typical Accountabilities:

Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements

Working with setting up submissions in Electronic Regulatory Vault (ERV)

Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.

Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals.

Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation

Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser

Provide coaching, mentoring and knowledge sharing within the RPM skill group

Contribute to process improvement

Essential Requirements:

Excellent written and verbal communication skills

Organized with project management skills

Experience in document management and tracking databases

Aptitude to learn new systems quickly

Cultural awareness

Proficiency with common document management tools

Ability to work independently and as part of a team

Continuous improvement and knowledge sharing focused

Desired Qualifications:

Relevant qualification and/or experience in science, administration or IT

1-6 years of revant experience from biopharmaceutical industry, or other relevant experience

Experience with Veeva Vault

Some regulatory/medical/technical experience

Knowledge of AZ business and processes

Some knowledge of AZ submission, compilation, publishing and approval processes, standards, systems and tools (applicable to internal candidates)

Great People want to Work with us Find out why:

Are you interested in working at AZ, apply today

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

Date Posted 15-May-2024

Closing Date 28-May-2024

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

#J-18808-Ljbffr

  • Regulatory Affairs Associate

    3 weeks ago

    Mississauga, 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...

  • Regulatory Affairs Associate

    2 weeks ago

    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...

  • Regulatory Affairs Associate

    2 weeks ago

    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...

  • Associate, Regulatory Affairs

    2 months ago

    Mississauga, Canada Natco Pharma (Canada) Inc. Full time

    **Associate, Regulatory Affairs** Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated generic pharmaceutical company focused on research & development, and the manufacturing of active pharmaceutical ingredients (API) and finished drug product formulations. The Regulatory Affairs department is responsible...

  • Regulatory Affairs Manager

    1 month ago

    Mississauga, ON, Canada The Portage Group Full time

    Company Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client. Position...

  • Regulatory Affairs Associate

    2 weeks ago

    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...

  • Regulatory Affairs Associate

    4 weeks ago

    Windsor, ON, Canada Jamieson Wellness Inc. Full time

    Overall ResponsibilitiesReporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Associate

    4 weeks ago

    Windsor, ON, Canada Jamieson Wellness Inc. Full time

    Overall ResponsibilitiesReporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies. The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as...

  • Regulatory Affairs Associate

    1 month ago

    Mississauga, Canada Seaford Pharmaceuticals Inc. Full time

    Under the direction of the department manager, the Regulatory Associate is responsible to carry out regulatory functions at Seaford Pharmaceuticals to ensure compliance with all regulatory requirements applicable to Seaford’s operations. This position is responsible to participate in the preparation and filing of regulatory submissions and correspondence...

  • Regulatory Affairs Associate

    3 hours ago

    Markham, ON, Canada Kelly Science, Engineering, Technology & Telecom Full time

    We are currently recruiting for a contract position for our pharmaceutical client for an ONSITE role. Location: Thornhill (Markham)- Hybrid/Onsite Duration: 6months contract with potential for extension Regulatory Affairs Associate Role: Responsible for regulatory activities in support of assigned Aesthetic and/or Consumer business unit products...

  • Associate, Regulatory Affairs

    1 month ago

    Mississauga, Canada Natco Pharma (Canada) Inc. Full time

    **About Natco**: Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated pharmaceutical company focused on R&D and the manufacturing of drug products. We are a trusted supplier of medicines evidenced from our work with the world’s largest drug companies. Natco is renowned for trust, reliability, and commitment...

  • Regulatory Affairs Specialist Associate

    18 hours ago

    Mississauga, Canada Zimmer Biomet Full time

    **Requisition Number**: AMER27090 **Employment Type**: Full-time **Location**: Mississauga **Job Summary**: Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around...

  • Regulatory Affairs Associate

    4 weeks ago

    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 with the...

  • Regulatory Affairs Associate

    4 weeks ago

    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 with the...

  • Regulatory Affairs Associate

    4 weeks ago

    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 with the...

  • Regulatory Affairs Associate

    2 days ago

    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...

  • Senior Regulatory Affairs Associate

    2 weeks ago

    Mississauga, Canada Boston Scientific Full time

    Additional Locations: Canada-ON-MississaugaDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With...

  • Senior Regulatory Affairs Associate

    2 weeks ago

    Mississauga, Canada Boston Scientific Full time

    Additional Locations: Canada-ON-MississaugaDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With...

  • Senior Regulatory Affairs Associate

    2 weeks ago

    Mississauga, Canada Boston Scientific Full time

    Additional Locations: Canada-ON-MississaugaDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With...

  • Senior Regulatory Affairs Associate

    1 week ago

    Mississauga, Canada Boston Scientific Full time

    Additional Locations: Canada-ON-MississaugaDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With...