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AstraZeneca Jobs – Employment Opportunities for Global Regulatory Affairs Director Careers In Mississauga, ON

AstraZeneca Jobs in Ontario:– Hurry ! great news for job seekers. AstraZeneca Jobs site publish notice for various jobs vacancy in their offices. Currently Global Regulatory Affairs Director Jobs available now. Candidates who are looking for Global Regulatory Affairs Director Jobs in Ontario with relevant required experience can apply for Global Regulatory Affairs Director careers Employment. Candidate will get after selection great Salary $ 144,389.00 Per Year.

AstraZeneca Jobs in Ontario Employment 

Name of the Recruitment Agencies/Department – AstraZeneca

Name of the Vacant Position – Global Regulatory Affairs Director

Job Location– Mississauga, Ontario

Salary – $ 144,389.00 Per Year

Jobs Type – Jobs In Canada

Job Description

ABOUT ASTRAZENECA

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

ASTRAZENECA in Canada

Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 straight years. Our collaborative work environment fosters knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making a meaningful impact where society needs it — health. We know the health of people, the planet and our business are interconnected, each impacting the others.

BUSINESS AREA

Within Oncology Regulatory Science and Strategy (ORSS) we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned product(s). You will serve as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs, or as regional regulatory lead. You’ll contribute significantly to overall product and clinical strategy. The role plays a key role influencing regulatory authorities through regular contacts to improve regulatory outcomes. The RAD leads cross-functional teams in major regulatory submissions (NDA, IND/CTA), health authority interactions, label discussions, and securing NDA/BLA approvals. As a GRL, the RAD leads the Global Regulatory Strategy Team (GRST) in formulating Global Regulatory strategy and delivering on NDA Filings and Approvals. Alternatively, as a regional regulatory lead, the RAD is a member of the GRST and is accountable for providing the region-specific Regulatory strategy and advice. The RAD serves as the face of the company with health authorities.

What you’ll do

  • Accountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products. Ensures that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. This includes health authority engagement strategy and considerations of expedited regulatory programs.
  • Lead cross-functional Teams in major health authority interactions. This includes setting the strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team through meetings rehearsals, and moderating the meeting itself.
  • Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team. Participate in coaching, and performance feedback to members of your GRST.
  • May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and be accountable for all Regulatory activities
  • Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. Lead preparation of the regulatory strategy document and target product labeling.
  • Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and participate in coaching, and performance feedback to members of the GRST.
  • Accountable for initiating and delivering key regulatory documents and plans and leading the negotiations with health authorities.
  • Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
  • Ensures appropriate planning and construction of the global dossier and core prescribing information led by the respective teams.  Accountable for product maintenance, supply and compliance activities associated with marketed brands.
  • Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

Essential for the role

  • An advanced degree in a science related field and/or other appropriate knowledge/experience.
  • Previous demonstrated experience of regulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labelling negotiations would be a plus.
  • A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.
  • Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
  • The ability to think strategically and critically and evaluate risks to regulatory activities.

Desirable:

  • A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
  • Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred.
  • Ability to work strategically within a complex, business critical and high-profile development program.
  • Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components

Why AstraZeneca?

This is the place to make a meaningful impact – on patients’ lives and your personal growth. It’s both rewarding and inspiring, and it’s what keeps us motivated every day.

Great People want to Work with us! Find out why:

  • GTAA Top Employer Award for 7 years:https://reviews.canadastop100.com/top-employer-astrazeneca-canada
  • Best Workplace Culture Award at the 2018 Canadian HR Awards:https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/
  • Browse AstraZeneca’s YouTube channel to find out more about us:https://www.youtube.com/user/astrazeneca

Are you interested in working at AZ, apply today!

AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship.  You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.AstraZenecais 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 [email protected]

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 authorisation and employment eligibility verification requirements.

Apply Now

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AstraZeneca Jobs – Employment Opportunities for Senior Clinical Data Manager Careers In Mississauga, ON

AstraZeneca Jobs in Ontario:– Hurry ! great news for job seekers. AstraZeneca Jobs site publish notice for various jobs vacancy in their offices. Currently Senior Clinical Data Manager Jobs available now. Candidates who are looking for Senior Clinical Data Manager Jobs in Ontario with relevant required experience can apply for Senior Clinical Data Manager careers Employment. Candidate will get after selection great Salary $ 170,797.00 Per Year.

AstraZeneca Jobs in Ontario Employment 

Name of the Recruitment Agencies/Department – AstraZeneca

Name of the Vacant Position – Senior Clinical Data Manager

Job Location– Mississauga, Ontario

Salary – $ 170,797.00 Per Year

Jobs Type – Jobs In Canada

Job Description

About AstraZeneca:

AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

AstraZeneca Canada:

Headquartered in Mississauga, Ontario, we’ve been recognized as one of Greater Toronto Area’s Top Employers for 7 straight years. Our collaborative work environment fosters knowledge-sharing, decision-making, and entrepreneurial thinking. Our employees have the opportunity to work across teams, functions, and even the globe. With a commitment to sustainability, we’re working towards making a meaningful impact where society needs it — health. We know the health of people, the planet and our business are interconnected, each impacting the others.

Our dynamic culture truly sets us apart. We support our people every day, focusing on three priorities: employee growth & development, health & wellbeing, and cultivating a vibrant, engaged and energized workplace. Through practical tools, resources, inspiring learning opportunities, and health and wellness support, we are helping our people thrive at work and beyond.

Our Oncology Research and Development Team:

Oncology is driven by speed. Here you will be backed by leadership and empowered at every level to prioritize and make bold moves. Our pioneering approach is identifying and treating patients earlier, focusing on early-stage cancer trials and listening and evolving based on their needs.

Join a dedicated Oncology team that’s growing fast and building a strong track record of success.

What you’ll do:

  • Coordinate deliverables on assigned projects depending on the relevant model and Data Management (DM) Vendor. Serves as the first line of contact at the project level.
  • Demonstrate leadership and operational knowledge in the planning and delivery of CDM deliverables at a project level under mentorship from a Principle Clinical data manager.
  • Responsible to identify risks and collaborate with the DM Vendor to mitigate the risk.
  • Understand therapeutic area, indication or program specific data capture standards and AZ standards.
  • Provide input into CDM related activities associated with regulatory inspections/audits.
  • Responsible for compliance to Trial Master File requirements relating to DM Vendor
  • Support Senior Leaders to coordinate CDM Vendor performance, depending on relevant model.
  • Review, assess and manage DM Vendor delivery against KPIs, budget and overall performance.
  • Coordinate vendor timelines and milestone deliverables for the assigned projects.
  • Ensures DM Vendor billing is accurate and gives recommendations for payment of invoices.
  • Drive adherence to AZ CDM standards and processes for data quality and consistency of data collecting.
  • Mentoring Clinical Data Managers or junior staff

Essentials for the role:

  • University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent
  • Ability to successfully lead simultaneous trials and meet deadlines while working with external partners
  • Solid knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry
  • Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
  • Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
  • Experience with query management process and reconciliation activities
  • Good communication and interpersonal skills including effective problem solving
  • Ability to work independently in a global team environment
  • Excellent written and verbal communication skills

Location: Head Office based position – Mississauga

Why AstraZeneca?

This is the place to make a meaningful impact – on patients’ lives and your personal growth. It’s both rewarding and inspiring, and it’s what keeps us motivated every day.

Great People want to Work with us! Find out why:

  • GTAA Top Employer Award for 7 years:https://reviews.canadastop100.com/top-employer-astrazeneca-canada
  • Learn more about our culture:https://www.linkedin.com/posts/genarestivo_greatpeople-greatplacetowork-topemployers2020-activity-6608742174811049985-N-8G
  • Browse AstraZeneca’s YouTube channel to find out more about us: https://www.youtube.com/user/astrazeneca

AstraZeneca is committed to taking every reasonable precaution to protect employees, our customers and the healthcare systems in the communities in which we serve. In an effort to protect the wellbeing of our employees and customers, full COVID-19 vaccination is an essential requirement of all positions at AstraZeneca. As such, all offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and AstraZeneca’s determination that the requested accommodation can be provided without undue hardship.You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

AstraZeneca is an equal opportunity employer, 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 [email protected]

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 authorisation and employment eligibility verification requirements.

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