AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines. As a FTSE 100 company with a presence in over 100 countries, it operates at a massive scale, employing nearly 90,000 people worldwide across therapy areas such as Oncology, Rare Diseases, and Cardiovascular, Renal & Metabolism.

In Spain, AstraZeneca maintains a robust presence with its commercial headquarters in Madrid and a significant global innovation hub in Barcelona. The company is a major employer for international talent, particularly in clinical research, data science, and regulatory affairs. Their Spanish operations are characterized by a multicultural environment and a strong emphasis on professional development, making them a top choice for expatriates in the life sciences sector.

AstraZeneca was formed in 1999 through the merger of the Swedish company Astra AB and the British Zeneca Group PLC. It has since evolved into a global pharmaceutical leader, notably playing a key role in the global response to the COVID-19 pandemic.

Regulatory Affairs Director

AstraZeneca

Requirements

An advanced degree in a science related field and/or other appropriate knowledge/experience.
At least 5-year experience of regulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labeling negotiations would be a plus.
A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.
Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
The ability to think strategically and critically and evaluate risks to regulatory activities.

Original Advert

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

Introduction to the role

The RAD provides strategic and operational regulatory leadership to the development,commercialisationand life cycle management of the assigned product(s).The RAD servesasthe global regulatory lead (GRL)onearly stageprojects or specific indications oflarger programs, or as regionalregulatory lead. Contributes significantly to overall product and clinical strategy.The role plays a key roleinfluencingRegulatory authorities through regular contacts to improve Regulatory outcomes.The RAD leadscross-functional Teams in major Regulatory Submissions (NDA, IND/CTA), Health Authority Interactions,Label discussions, and securingNDA/BLAApprovals.As a GRL the RAD leads theGlobalRegulatoryStrategyTeam(GRST)in formulating Global Regulatory strategy and delivering on NDA Filings and Approvals.Alternatively, as a regional regulatory lead, the RAD is a member of the GRST and is accountable for providing the region-specific Regulatory strategy and advice.The RAD servesas the face of the company with Health Authorities.

Typical Accountabilities

Accountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products.Ensuresthat the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needsidentifiedby the business,marketsand patients. This includeshealthauthority engagement strategy and considerations of expedited regulatory programs.

Lead cross-functional Teams inmajor health authority interactions. This includessettingthe strategy and planning for the interaction, driving the formulation of the briefing document focused on strategy and scientific content, leading the team throughmeetingsrehearsals, and moderating the meeting itself.

Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.Participate in coaching, and performance feedback to members of your GRST.

May (depending on role and project) represent Regulatory Affairs on Global Product Teams (GPTs)providingstrategic Regulatory advice and be accountable for all Regulatory activities

Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations.Lead preparation of the regulatory strategy document and target product labeling.

Demonstratestrategic leadership skills contributing to effective product development.Provide team leadership andparticipatein coaching, and performance feedback to members oftheGRST.

Accountable for initiating and delivering key regulatory documents and plans and leading the negotiations with health authorities.

Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.

Ensuresappropriate planningand construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance, supply and compliance activities associated with marketed brands.

Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

Education, Qualifications,Skillsand Experience

Essential

An advanced degree in ascience relatedfield and/or otherappropriate knowledge/experience.

At least 5-yearexperience ofregulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labeling negotiations would be a plus.

A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.

Demonstratedcompetencies of strategic thinking, strategic influencing, innovation, initiative,leadershipand excellent oral and written communication skills.

The ability to think strategically and critically and evaluate risks to regulatory activities.

Desirable

A good understanding of guiding principles in drug development such as benefit/risk profile, doseselectionor statistical design.

Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapyarea(small molecules & biologics) is preferred.