Regulatory Affairs Manager

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

For assigned products: Design regulatory strategy for new drug application, additional indications in alignment with lead/ director RA and timely execution of proactive preparation and submissions, query responses and SEC preparedness. Lead to ensure timely Site registration fresh/ renewal. Regulatory support to clinical trials application and compliance. Ensure regulatory support to License Life cycle management and regulatory compliance internally and externally. Handle artwork management.

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 on fast track to facilitate early launch
• Support RA Leadership for regulatory policy shaping and regulatory advocacy
• Regulatory competitive Intelligence and analysis

Activities

• 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 breach of codes or conducts
• Monitor status of product licenses
• Project manage changes in product licenses and coordinate with other changes, planned and in progress
• Maintain complete documentation records
• Communicate changes to licenses status promptly
• Lead regulatory strategy for assigned new launches in conjunction with key stakeholders and flawless execution of strategy by ensuring timely submission and fast track approval including SEC preparedness, query responses etc
• Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy.
• Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch.
• Impactful collaboration across cross functional teams- Supply, QA, Medical, Business, access, policy etc.
• Guidance to junior RA associates/ contract associates
• Support development of Junior RA associates
• Regulatory filing/ approval of global/ local clinical trial application including query responses, SEC preparedness
• Support regulatory activities during study conduct till study closure
• Ensure regulatory compliance for life cycle maintenance products and clinical trials as per internal and external norms including post approval commitments
• Timely completion regulatory database
• Support Promotional material review
• Preparation for relevant Audits if any and CAPA actions/ deviations
• Artwork management
• Monitor and understand the impact of external changes in the regulatory and political environment with impact assessment and communicate to key stakeholders.
• Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes
• Support RA leadership for regulatory policy shaping
• Actively participate in Industry association meetings as assigned
• Monitor the global pipelines of competing pharmaceutical companies · Analyze gathered information for its impact on AstraZeneca proposed pipelines
• Provide scenario with options and a risk – benefit analysis for AstraZeneca going forward

Internal customers

Marketing, Sales, Logistics, Medical, Legal Affairs Intellectual Property, Clinical Operations, 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:

M.Pharm/ B.Pharm/ M.Sc with 8-10yrs Experience in India Regulatory function, knowledge of dossier compilation. He/ she should be conversant with Indian regulations.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s 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. We’re on an exciting journey to pioneer the future of healthcare

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.