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Senior Director/Director, Global Regulatory Affairs Early Respiratory

4 months ago

Mississauga, Canada AstraZeneca Full time

Do you have leadership skills and an in depth knowledge within Regulatory Affairs? Do you want to work on innovative projects of importance for our early Respiratory and Immunology portfolio?

At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transform patient outcomes. This means our people are here to win, we give you a breadth of opportunities to be curious and do groundbreaking, unique work that has significant impact on science, medicines and patients.

The Global Regulatory Affairs Therapeutic area team that you will belong to is a strategic function within the Respiratory & Immunology Development organisation. The Regulatory Affairs team leads the development and execution of regulatory strategies for global programmes across the entire lifecycle by proactively demonstrating and applying the broad regulatory and scientific expertise, leadership skill and eye for business to identify and champion innovative and impactful regulatory pathways and drug development strategies to benefit patients.

We now have a great opportunity for you to join our team within Respiratory and Immunology (R&I) in the roles as Senior Global Regulatory Affairs Director or Global Regulatory Affairs Director. These roles can be based at AstraZeneca’s dynamic R&D sites in Barcelona (Spain), and Boston (US).

What you’ll do:

The Global Regulatory Affairs Directors are accountable for leading the development and implementation of the global regulatory strategy for a project or a group of products of increasing complexity within the R&I portfolio. You will ensure that the strategy is designed to deliver rapid approval with advantageous labelling in keeping with the properties of the products and the needs identified by the business, markets and patients.

These roles will have a focus on the Early Development (up to phase 2b), innovation, novel modalities and new progressive endpoints. As a Global Regulatory Affairs Director, you will have the ability to take on the Global Regulatory Lead (GRL) role for one or more products and to function in dual capacity by delivering the overarching global regulatory strategy as well as serve as a regional regulatory lead.

Your main accountabilities/responsibilities:

Work on cross-project initiatives of high importance for the early R&I portfolio

Lead the development and implementation of innovative global strategies of increasing complexity to improve the likelihood of regulatory success

Accountable for the delivery of all regulatory achievements including assessment of the probability of regulatory success together with risk analysis and mitigation measures

Serve as the single point of contact and GRL/Regional Lead on early Global Project Teams (eGPTs)

Lead the Global Regulatory Strategy Team (GRST) or as a Regional Lead with key contributing members from regional perspectives, international markets, Regulatory CMC as well as regulatory delivery & enablement

Lead key cross-department or cross-functional projects on behalf of Global Regulatory Affairs (GRA) when necessary

Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal

Participate in skill-development, coaching, and performance feedback of other regulatory staff

Capability and credibility in complex, business critical projects and ability to cope with ambiguity and lead senior key partners.

Essential for the role:

To be a successful in these roles, you have a Bachelor's degree in a science related field.

More than 7 years’ experience or equivalent of regulatory drug development including working on early development projects is needed.

A broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, Global, European, International, Marketing Company or experience at a health authority.

Curious and eager to learn about novel modalities and what it would take to develop these into successful products from a regulatory perspective.

Strategic leadership skills, a deep understanding of global regulatory science and overall drug/biologic development processes.

Excellent oral and written communication skills.

Desirable for the role:

Experience and knowledge within the Respiratory or Immunology disease areas is an advantage, but not a formal requirement. Also, previous experience of working with strategies for novel development programs is preferred as well as previous experience in leading Major Health Authority interactions ( FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.).

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you

Where can I find out more?

Date Posted

28-May-2024

Closing Date

29-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.