Senior Director/Director, Global Regulatory Affairs Early Respiratory & Immunology at AstraZeneca

Posted in Other 11 days ago.

Location: Gaithersburg, Maryland

Job Description:

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 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 leveraging and applying the broad regulatory and scientific expertise, leadership skill and business acumen to identify and champion innovative and impactful regulatory pathways and drug development strategies to benefit 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 Gaithersburg and Durham (US); Gothenburg (Sweden); Macclesfield (UK) 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 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 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 Sub-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 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!

If you have any questions regarding the role, please reach out Talent Acquisition Partner

We will review the applications continuously so please apply as soon as possible.

Where can I find out more?

AZ Gothenburg

AZ Gaithersburg

Respiratory & Immunology

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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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