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Regulatory Affairs Project Manager - Oncology

Местоположение Миссиссога, Онтарио, Канада Идентификатор вакансии R-103934 Дата публикации 04/05/2021

Regulatory Affairs Project Manager - Oncology

Do you have expertise in, and passion for, Regulatory Affairs? Would you like to apply your expertise to impact the lives of patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

Position Type: Permanent, Full Time

Location: Mississauga, Head Office

Career Level: D

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 impactwhere society needs it —health. We know the healthof people, the planet and ourbusiness 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.

Regulatory Affairs and Quality Assurance

Be part of a global, winning team filled with the smartest minds. Our diversity is our strength, it reflects the variety of patients we serve. We strive to create a place where everyone is empowered to speak up and share ideas, and we welcome alternative perspectives to push our thinking further, together.

Regulatory Affairs Project Managers provide regulatory input and direction to the Canadian Cross Functional Team and Global regulatory teams to build regulatory strategies, deliver optimal Health Canada approvals (time and quality), maintain compliance and positively impact a product's potential and lifecycle in the Canadian marketplace.

What you’ll do

  • Assume role of Regulatory Affairs lead for one or more oncology brands

  • Collaborate with the Brand/Lifecycle teams(s) by providing strategic and informed regulatory/business expertise

  • Prepare, submit and negotiate approvals of NDSs and Clinical SNDSs

  • Ensure regulatory submissions are compliant with both HPFB and AstraZeneca requirements and standards

  • Work closely with the Global cross-functional team to develop regulatory strategies, deliver submissions, and secure optimal review outcomes.

  • Maintain regulatory compliance of approved products

  • Build and implement regulatory strategic plans including Regulatory Strategy Documents

  • Investigate and execute on accelerated regulatory review pathways to address areas of unmet need

  • Plan and conduct Health Canada meetings for the purpose of scientific exchange and pre-submission planning

  • Prepare key external experts and Global cross-functional team for Health Canada meetings

  • Influence the global development of products, representing the Canadian market, to mitigate regulatory risks in the development plans

  • Work with external experts and participate in key external advisory boards to enhance understanding of Canadian clinical practice and clinical relevance of emerging data

  • Build and release Health Professional and Public Communications

  • Review and approve promotional materials and external communications

  • Compile responses to ATI requests

  • Provide comments on emerging Canadian regulations/policies/guidelines/initiatives/surveys

  • Provide expertise and support to junior staff members (associates, students and assistants) to positively encourage development and knowledge transfer

Your qualifications include:

  • B.Sc. or equivalent in a related (health science) discipline; advanced degree (M.Sc. or Ph.D.) is an asset

  • Strong knowledge of the Canadian regulatory environment and Health Canada regulations, policies and guidelines

  • Knowledge of Oncology and/or Rare Disease therapeutic areas is an asset

  • Minimum 3-5 years regulatory experience in the brand name pharmaceutical or biotechnology industries

  • Minimum 2 years regulatory project management experience

  • Proficient in the use of MS Office

Your strengths include:

  • Positive interpersonal and relationship building skills with the ability to work effectively as part of a team

  • Superior negotiation skills

  • Strong decision-making, strategic and innovative thinking capabilities

  • Ability to identify and execute on opportunities and risks and problem solve

  • Agility, excellent time management and organizational skills (able to manage multiple projects and priorities effectively)

  • Keen attention to detail 

  • Strong written and verbal presentation skills and adept at crafting business proposals and project plans

Why 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, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

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

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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