DIRECTOR - test
Typical Accountabilities:
• Accountable for the development and implementation of the regulatory strategy for a product/ group of products, and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, and patients
• Accountable for product maintenance, supply and compliance activities associated with marketed brands
• Delivers all regulatory milestones including assessment of the approvability of the program together with risk mitigation measures
• Leads the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities
• Works collaboratively with the global/regional/local regulatory affairs staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally. Ensures effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements
• Leads the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality
• Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
• Leads the review of key submission documents and identify any potential risks along with possible contingencies to ensure the earliest appropriate submission and earliest possible approval of key deliverables with advantageous labelling
• Creates, communicates and updates the Regulatory Strategy Document for assigned products/projects. Ensures appropriate consultation and Peer Review. Defines the regulatory development plan and own the planning and construction of the global dossier and core prescribing information
• Provides regulatory leadership as needed in product license-in/due diligence review, product divestment and product withdrawal
• Ensures excellent understanding of the commercial/business goals to contribute as an equal partner with medical and commercial colleagues in cross functional delivery of business objectives
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
Typical People Management Responsibility (direct / indirect reports):
• Approximate number of people managed in total (all levels) - varies
• Matrix Manager – (projects/dotted line)
• Manager of a team
What is the global remit? (how many countries will the role operate in?):
• 2 or 3 countries at a minimum of 40% of time
Education, Qualifications, Skills and Experience:
• Essential: Bachelor’s Degree in Life Science or related discipline, advanced degree a plus.; Substantial direct experience of working at the Regulatory Authority interface and leading delivery of regulatory projects through key milestones and investment decisions.; Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company, CMC, SMG, etc., or experience at a health authority.; Proven leadership and program management experience.; Consistently demonstrating an ability to think strategically and critically evaluate risks to regulatory activities, taking account of external trends in both regulatory and business environment.
• Desirable: Strategic Influencing – through well thought out rationale and effective communication skills, able to influence key decisions.; Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas; Builds effective partnerships – identified opportunities and takes actions to build effective relationships within team and with other areas; Leadership – effectively role models the culture & values and expertly guides the team to its common mission.; Coach and mentor to others – sought out to mentor others and identifies as well as develops regulatory talent, with commitment to learning and personal development.; The ability to work in a complex, business critical and high profile environment building credibility in ambiguous situations.; Courage in communicating regulatory decisions and/or risks which will be met with resistance by key stakeholders
Key Relationship to reach solutions:
• Internal (to AZ or team): VP; Regulatory TA; VP Regulatory Regions; GPT/EPT members; TAPT; PRB; Regional Business staff; AZRA; Senior Management
• External (to AZ): Health authority personnel; Trade Association members; External Advisory Boards
• Accountable for the development and implementation of the regulatory strategy for a product/ group of products, and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, and patients
• Accountable for product maintenance, supply and compliance activities associated with marketed brands
• Delivers all regulatory milestones including assessment of the approvability of the program together with risk mitigation measures
• Leads the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities
• Works collaboratively with the global/regional/local regulatory affairs staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally. Ensures effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements
• Leads the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality
• Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project
• Leads the review of key submission documents and identify any potential risks along with possible contingencies to ensure the earliest appropriate submission and earliest possible approval of key deliverables with advantageous labelling
• Creates, communicates and updates the Regulatory Strategy Document for assigned products/projects. Ensures appropriate consultation and Peer Review. Defines the regulatory development plan and own the planning and construction of the global dossier and core prescribing information
• Provides regulatory leadership as needed in product license-in/due diligence review, product divestment and product withdrawal
• Ensures excellent understanding of the commercial/business goals to contribute as an equal partner with medical and commercial colleagues in cross functional delivery of business objectives
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration
Typical People Management Responsibility (direct / indirect reports):
• Approximate number of people managed in total (all levels) - varies
• Matrix Manager – (projects/dotted line)
• Manager of a team
What is the global remit? (how many countries will the role operate in?):
• 2 or 3 countries at a minimum of 40% of time
Education, Qualifications, Skills and Experience:
• Essential: Bachelor’s Degree in Life Science or related discipline, advanced degree a plus.; Substantial direct experience of working at the Regulatory Authority interface and leading delivery of regulatory projects through key milestones and investment decisions.; Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company, CMC, SMG, etc., or experience at a health authority.; Proven leadership and program management experience.; Consistently demonstrating an ability to think strategically and critically evaluate risks to regulatory activities, taking account of external trends in both regulatory and business environment.
• Desirable: Strategic Influencing – through well thought out rationale and effective communication skills, able to influence key decisions.; Ability to gain commitment – effectively uses interpersonal abilities to build relationships and gain acceptance of ideas; Builds effective partnerships – identified opportunities and takes actions to build effective relationships within team and with other areas; Leadership – effectively role models the culture & values and expertly guides the team to its common mission.; Coach and mentor to others – sought out to mentor others and identifies as well as develops regulatory talent, with commitment to learning and personal development.; The ability to work in a complex, business critical and high profile environment building credibility in ambiguous situations.; Courage in communicating regulatory decisions and/or risks which will be met with resistance by key stakeholders
Key Relationship to reach solutions:
• Internal (to AZ or team): VP; Regulatory TA; VP Regulatory Regions; GPT/EPT members; TAPT; PRB; Regional Business staff; AZRA; Senior Management
• External (to AZ): Health authority personnel; Trade Association members; External Advisory Boards
Date Posted
14-May-2025Closing Date
24-Jun-2025AstraZeneca 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.
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