Lead Regulatory Affairs
Lead Regulatory Affairs
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Job Description
About AstraZeneca
AstraZeneca 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 Lead
Reports to Director - Regulatory Affairs
Position purpose
For 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 mats
Internal 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 Office
External customers CDSCO Office NIB IPC CDTL CDL NCB & DCK and other Local Health Authorities and other Government Agencies Manufacturers Local Trade Associations Legal Professionals
Minimum requirements Qualification: 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 Adherence to AZ and industry codes of conduct ethics and good regulatory practices Ensure that all licensing for assigned products is complete in accordance with relevant norms Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate the rapid launch Provide Leadership and direction within project teams Assist in Issue Management Maintain the awareness of and shape the regulatory environment relevant to the assigned products portfolio Competitive Intelligence and analysis
Key Result Areas/outputs Activities
Adherence to AZ and industry codes of conduct ethics and good regulatory practices Align with the values and vision of AZ Ensure compliance with Local legislation Global regulatory policies AZ code of conduct Corporate Governance and Audit requirement Ensure that company confidentiality is maintained (i.e. intellectual property product information and strategic information) Disclose potential breaches of codes or conducts
Key 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 Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products Communicate the impact of changes to key stakeholders. Influence key external stakeholders in line with codes of conduct to improve regulatory outcomes Develop excellent relationships and partnerships with Regulatory Authorities
Competitive Intelligence and Analysis Monitor the global pipelines of competing pharmaceutical companies Analyse gathered the information for its impact on AstraZenecas proposed pipelines Provide a scenario with options and a riskbenefit analysis for AstraZeneca going forward
Key result areas/outputs Activities
GRP Quality Lead Ensuring the GxP area(s) under their responsibility are run in accordance with external regulations. Ensuring appropriate levels of resources to complete GRP activities Providing/coordinating training and coaching in the related GxP area for the MC QMS Identifying/agreeing on areas of compliance risk and follow-up of any issues Ensuring GxP self-assessments in the corresponding GxP area Monitoring KPIs in the related GxP area and proposing remedial and improvement actions Establishing improvement priorities Monitoring internal/external factors such as emerging regulations or shifts in regulatory enforcement Identifying trends and communicating identified risks Establishing and maintaining business continuity plans in the corresponding GxP are
Why 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.
Employment Type
Full-Time
