Senior Director/Director, Global Regulatory Affairs Early Respiratory - Boston, MA, United States - AstraZeneca GmbH

Description

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?

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.

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.

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.

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.

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, e.g.

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.
Experience and knowledge within the Respiratory or Immunology disease areas is an advantage, but not a formal requirement. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.).