Senior Director/director, Global Regulatory Affairs - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

Do you have strategic leadership skills and an in depth knowledge within
Regulatory Affairs? Do you want to work on
innovative projects of high 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. By 2030 our bold ambition is to deliver 20 new medicines, industry leading growth and be carbon negative.

This means our people are here to win and we will give you a breadth of opportunities to learn, to be curious and do cutting edge, unique work that has significant impact on science, medicines and patients.

The role

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
Gothenburg (Sweden),
Macclesfield (UK),
Gaithersburg and Durham (US) or Barcelona (Spain).

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 transformative 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 crossproject initiatives of high importance for the early R&I portfolio
Lead the development and implementation of innovative global strategies of increasing complexity to maximize the likelihood of regulatory success
Accountable for the delivery of all regulatory milestones 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 Subteam (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 crossdepartment or crossfunctional projects on behalf of Global Regulatory Affairs (GRA) when necessary
Provide regulatory leadership as needed in product inlicense/due diligence review, product divestment and product withdrawal
Participate in skilldevelopment, coaching, and performance feedback of other regulatory staff
Capability and credibility in complex, business critical projects and ability to cope with ambiguity and manage senior key stakeholders.

Do you have the essential qualifications for these roles?

To be a successful in these roles, we believe that you have an advanced degree in a science related field and/or other appropriate knowledge/experience.

More than 7 years' experience or equivalent of regulatory drug development including working on early development projects is needed, and we believe that you have a broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g.

Global, European, International, Marketing Company or experience at a health authority.

We believe you are curious and eager to learn about novel modalities and what it would take to develop these into successful products from a regulatory perspective.

To do this you have strategic leadership skills, a deep understanding of global regulatory science and overall drug/biologic development processes.

Excellent oral and written communication skills are

needed in these roles.

Desirable Requirements:

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 (e.g. 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?
AZ Gothenburg

AZ Gaithersburg

Respiratory & Immunology