Director Global Regulatory Policy (International Regulatory Affairs) & New Modalities Strategy

Job Description

Job Description

This role is a combined role with responsibility as international regulatory policy director and product lead for new modalities working closely with International Policy & Intelligence Lead, Marketing Companies, and regional and global Functions.

Policy:

The International Director Regulatory Policy is responsible for driving internationally impacting regulatory policy development and advocacy in cooperation with global, regional, local and functional experts.

The Director provides a broad strategic view for regulatory policy issues based on in-depth knowledge of the internal and external regulatory environment in International Regions (Asia, Eurasia, Latin America and Middle East & Africa).The Director will contribute to and co-develop policy positions including stakeholder interactions and help to implement these policy positions regionally , leading to more impactful external engagements for AZ’s disease areas of interest, new therapeutic modalities, CMC & quality, and cross-area topics.

The Director will be a major participant articulating AZ’s consolidated view on key international and local regulatory guidances and regulations. This includes maintaining and developing key health authority relationships and being able to influence proposed rules and regulations that specifically impact AZ and ultimately the pharmaceutical industry. The incumbent can also lead implementation of changes to international strategy and processes due to significant regulatory environment changes (new legislation/guidance etc) and can lead AZ’s response to key regulatory policy topics on a Global and International basis. The director will assess impact of new legislative/environmental changes on product strategy and communicate relevant information to inRA iRADs for onward communication to GPTs

The Director will have a major role interacting with other parts of the AZ organization that are influencing policy and legislation at local, regional, and global levels and devdeloping advocacy plans for their areas of responsibility whilst capturing key KPIs and metrics.

The Director attends relevant external meetings or conferences of value to the business, and contributes to the overall strategy, direction and efficient operation of the function. There will be an opportunity for the incumber to engage with Governments, trade associations, and other stakeholders on international policy issues and represent AZ in the relevant platforms externally.

New Modalities Strategy:

As a New Modalities Strategy Lead, you will provide strategic and operational regulatory leadership for the development, commercialization, and lifecycle management of assigned products in new modalities (including but not limited to radioligands and/or cell & gene therapies). You will serve as the international regulatory strategy and operations lead on early-stage projects or specific indications of larger programs. Your role will be pivotal in identifying risks influencing both regulatory authorities and in house GPTs/GRSTs through regular interactions to enhance regulatory outcomes. You may lead cross-functional teams in major regulatory submissions, health authority interactions, label discussions, and securing international NDA/BLA approvals. As an international regulatory strategy and operations lead, you will guide the International Regulatory Team (IRT) in formulating International regulatory strategies and delivering on NDA filings and approvals. You will drive innovation and excellence in regulatory affairs by creating regulatory strategies that push the boundaries and use innovative pathways.

Typical Accountabilities

Policy

• Lead or manage regulatory policy priority topics as coordinated by the Global Regulatory Policy Team /International Policy and Intelligence lead
• Provide key regulatory procedural/ environmental advice on assigned topics to key customers/stakeholders within international and Global, including the Regulatory TAs, Commercial, MC regulatory, R&D, Operations and CMO functions.
• Support preparation of regulatory policy documents, including position statements, reports, draft papers and presentation materials.
• Support with the oversight and management of international policy and intelligence scorecard KPIs, and its metrics for performance internally and externally
• Lead and develop the International Regulatory Policy Training Capability Framework
• Establish the international CMC-RA Policy Framework in collaboration with international CMC RA
• Represent AZ International Regulatory Affairs on selected external International Trade Association committees to ensure AZ International Regulatory views on key issues are known
• Attend relevant external meetings/conferences to obtain relevant intelligence of value to the business and communicate effectively.
• May represent AZ in external benchmarking on advocacy business practices.
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
• Contribute to the strategy, direction and efficient operation of the immediate team and function.

Product Lead

• Lead the development and implementation of international regulatory strategies for products, ensuring rapid approval with competitive labeling.
• Drive cross-functional teams in major health authority interactions, from strategy formulation to meeting moderation.
• Lead the International Regulatory Strategy Team (IRT) in planning and implementing regulatory strategies.
• Represent International Regulatory Affairs at Global Regulatory Strategy Team (GRST), providing strategic advice and overseeing all regulatory activities.
• Achieve regulatory achievements, evaluate regulatory success probabilities, and spearhead preparation of strategy documents and product labeling.
• Initiate and deliver key regulatory documents, negotiate with health authorities, and manage emerging data assessments.
• Ensure international dossier planning and product maintenance compliance.
• Collaborate with marketing companies and cross functional teams to influence developing views and guidance

Education, Qualifications, Skills and Experience

Essential

• 8+ years in global regulatory affairs, including international regions (Asia, Latin America and Middle East & Africa)
• Understands the role of external policy and advocacy and connections to business goals in the International Regions.
• Demonstrated expertise in Regulatory policy related matters, through Health Authority or Industry experience, and more specifically in two or more International Regions such as Asia, Eurasia, Latin America and Middle East & Africa.
• Working knowledge of AZ focused disease areas, new therapeutic modalities, CMC& quality, and cross-area topics.
• Thorough understanding and application of the Drug Development and associated regulatory processes globally and internationally. 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.
• Working experience in developing and executing new product strategies for global and international regions across different therapeutic areas
• A collaborative, entrepreneurial mindset—comfortable with ambiguity and adept at building from the ground up
• Demonstrated proficiencies in critical thinking, critical influencing, innovation, initiative, leadership and excellent oral and written communication skills.
• The ability to think strategically and critically and evaluate risks to regulatory activities.
• Collaborative and able to building consensus with peers and leadership (ability to influence upwards)
• Strong oral and written communication skills
• Experience in knowledge management and digital information management

Desirable

• Experience working in Health Authority
• Problem solving skills
• Focus on delivery and results
• Experience in new modalities ie antibody conjugates, cell and gene therapy, radiotherapeutics
• Experience of participating in key industry groups and policy fora
• Excellent strategic influencing and negotiation
• Experienced Regulatory Professional with degree in scientific discipline, typically pharmacy and biological science.
• Experience or aptitude in using AI/Gen AI within regulatory space

Date Posted

Closing Date

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.