Job Description

About AstraZenecaAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies.Lead Regulatory Affairs & GRP LeadReports to Director - Regulatory AffairsPosition purposeFor assigned products: Regulatory Acceleration process Plan to gain rapid and high-quality approvals and ensure a high standard of regulatory compliances, SEC/TC/APEX Preparation, in order to achieve the companys business objectives. Developing India-specific Artwork, Support to Regulatory dossier preparation and submissions like New drug applications, Site registration, Clinical trials and Import licence. Managing Registration samples right from dispatch of samples till the report. As part of a New drug application, ADC sample testing. Also follow up for reports, Licence Life cycle management. Revision of existing licenses, and artworks, where gaps are identified, for compliance with existing licenses. Facilitates a second review of external submissions. Handling of promo matsInternal customers Marketing, Sales, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams (GPTs), Key Brand Teams (KBTs), International Regulatory Affairs (IRA), Manufacturing Sites and QA, Regional OfficeExternal customers CDSCO Office, NIB, IPC, CDTL, CDL, NCB, & DCK and other Local Health Authorities and other Government Agencies, Manufacturers, Local Trade Associations, Legal ProfessionalsMinimum requirements Qualification: M.Pharm/B.Pharm/ 10-14 years Experience in India Regulatory function, knowledge of dossier compilation. He/ she should be well conversant with Indian regulations.Key Result Areas/ outputs xc2xb7 Adherence to AZ and industry codes of conduct, ethics and good regulatory practices xc2xb7 Ensure that all licensing for assigned products is complete in accordance with relevant norms xc2xb7 Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate the rapid launch xc2xb7 Provide Leadership and direction within project teams xc2xb7 Assist in Issue Management xc2xb7 Maintain the awareness of, and shape the regulatory environment relevant to the assigned products portfolio xc2xb7 Competitive Intelligence and analysisKey Result Areas/outputs ActivitiesAdherence to AZ and industry codes of conduct, ethics and good regulatory practices xc2xb7 Align with the values and vision of AZ xc2xb7 Ensure compliance with Local legislation, Global regulatory policies, AZ code of conduct, Corporate Governance and Audit requirement xc2xb7 Ensure that company confidentiality is maintained (i.e. intellectual property, product information and strategic information) xc2xb7 Disclose potential breaches of codes or conductsKey Result Areas/outputs Activities

• . Ensure that all licensing for assigned products is complete in accordance with relevant norms

• Monitor status of product licenses
• Manage changes in product licenses and coordinate with other changes, planned and in progress
• Maintain complete documentation records
• Communicate changes to licenses status promptly
• Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch

• Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy
• Ensure that local regulatory strategies are consistent with global product strategies and local priorities
• Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time
• Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch
• Provide Leadership and direction within project teams

• Strive to ensure high levels of performance and achievements.
• Take decisions and accountability for actions.
• Build commitment within the team.
• Enhance positive attitudes and mindset.
• Demonstrate confidence and conviction.

• Challenge the status quo for continuous improvement.
• Help build an open and trusting atmosphere
• Assist in Issues.

• Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals/permissions xc2xb7 Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products xc2xb7 Communicate the impact of changes to key stakeholders. xc2xb7 Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes xc2xb7 Develop excellent relationships and partnerships with Regulatory Authorities

Competitive Intelligence and Analysis xc2xb7 Monitor the global pipelines of competing pharmaceutical companies xc2xb7 Analyse gathered the information for its impact on AstraZenecas proposed pipelines xc2xb7 Provide a scenario with options and a riskbenefit analysis for AstraZeneca going forwardKey result areas/outputs ActivitiesGRP Quality Lead xc2xb7 Ensuring the GxP area(s) under their responsibility are run in accordance with external regulations. xc2xb7 Ensuring appropriate levels of resources to complete GRP activities xc2xb7 Providing/coordinating training and coaching in the related GxP area for the MC QMS xc2xb7 Identifying/agreeing on areas of compliance risk and follow-up of any issues xc2xb7 Ensuring GxP self-assessments in the corresponding GxP area xc2xb7 Monitoring KPIs in the related GxP area and proposing remedial and improvement actions xc2xb7 Establishing improvement priorities xc2xb7 Monitoring internal/external factors such as emerging regulations or shifts in regulatory enforcement xc2xb7 Identifying trends and communicating identified risks xc2xb7 Establishing and maintaining business continuity plans in the corresponding GxP areWhy AstraZeneca?At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. Were on an exciting journey to pioneer the future of healthcare.Date Posted 26-May-2025Closing Date 30-Jul-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.