Work as Global Regulatory Lead @ AstraZeneca
The Associate Director – Product Regulatory Affairs is 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 for regulatory maintenance activities in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. The Associate Director – Product Regulatory Affairs possesses strategic leadership skills, has an understanding of regional (US or EU) and/or global regulatory science and overall drug/biologic maintenance processes and strategies. Experience and knowledge of the disease area is an important enabler to being able to influence cross-functional discussions with regional and/or global product teams and relevant stakeholders.
Accountable for the development and implementation, at a regional or global level, of innovative regulatory strategies and for ensuring that the strategy is designed to deliver a rapid approval of regulatory maintenance activities.
Leads the Global Regulatory Strategy Team (GRST) with key contributing members from a regional perspective, Manufacturing (Operations) and Regulatory Project Managers, to ensure prioritized objectives are delivered to time and quality. Through the GRST, ensures that regional regulatory needs for post-approval changes and post-approval commitments are identified and incorporated into an optimum Global Regulatory Strategy that in turn contributes to the Global Product Plan.
Serves as the single point of contact and Global Regulatory Affairs (GRA) representative on Regional and/or Global Product Teams.
Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures for post-approval changes and post-approval commitments.
Accountable for CDS/SmPC/USPI updates, and approval of regulatory impositions to market product information.
Accountable for product maintenance, supply and compliance activities associated with marketed brands.
Lead regulatory defense interactions and provide regulatory leadership to issue management teams.
Lead ad-hoc regulatory interactions, ensuring effective regulatory representation in partnership with appropriate technical experts at all health authority meetings.
Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise regional and/or Global Product Teams (GPT) accordingly.
Provide regulatory leadership as needed in product divestment and product withdrawal.
Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
• University Degree in Science or related discipline
• 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.
• >13 years relevant regulatory experience, including license maintenance and labelling, and of working across a range of markets, including regulated markets
• Thorough knowledge of the regulatory product maintenance process
• Leadership skills, including proven leadership of cross-functional project teams experience
• Excellent English written and verbal communication skills
• Thorough scientific knowledge sufficient to understand all aspects of regulatory issues
• Proven ability to think strategically and critically evaluate risks to regulatory activities.
• Proven ability to work strategically within a complex, business driven, regulated environment.
• Experience of working with people from locations outside of India, especially Europe and/or USA
• Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions
Skills and Capabilities
• Strategic thinking
• Supplier and Partner management
• Project management
• Strategic Influencing
• Problem solving
• Team working
• Customer focused
• Understanding of the importance of Continuous Improvement
• Knowledge sharing
Internal and External Contacts/Customers
– Internal science functions
– Manufacturing organisation
– Marketing Companies/Local Affiliates
– Patient Safety organisation
– Health Authorities
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