Executive Assistant Regulatory Affairs

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.

Job Description/ Capsule

• Collates information communicates and prepares responses for Health Authority queries to facilitate regulatory processes.
• Maintains and updates submission trackers to ensure accurate and up-to-date regulatory documentation.
• Supports the development of India-specific artwork ensuring compliance with regulatory requirements.
• Supports the preparation and submission of regulatory dossiers for new drug applications additional indication GCT applications site registrations and import licenses as and when assigned.
• Coordinates lifecycle management activities for assigned products addressing renewals and updates as needed.
• Prepares and submits Periodic Safety Update Reports (PSURs) as and when assigned.

• Support team for testing of samples by preparing and submitting required documents and letters to NIBL or CDTL.
• To support any additional upcoming RA project as and when delegated.

Core Accountabilities

Key Result Areas/ outputs:

Adherence to AZ and industry codes of conduct ethics and good regulatory practices Ensure that all licensing activities for assigned products are completed in full compliance with all applicable regulations and relevant standards.

Assist in Issue Management

Regulatory Intelligence

Management of India PSUR submission

Handles submission/review/query responses for commercial products/global clinical trials including SEC preparation

Maintain complete documentation records and all trackers maintained

Manage changes in product Licenses and coordinate with changes planned and in progress

Support relevant Audits internal and external

Support Deviations and CAPA as required

Learn or gain detailed knowledge of critical aspects of products: commercial strategies the content of dossiers regulatory intelligence regulatory timelines and supply strategy and proactive preparation of required steps manage local testing and legal documents for new launches.

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 breach of codes or conducts. Ensure that all licensing activities are completed in full compliance with all applicable regulations and relevant standards.

Support in application compilation and the respective query management and communicating the progress till approval/closure within RA team.

Assist in Issue Management

Provide detailed information of regulatory status of affected products

Undertake assigned follow-up action where necessary

Regulatory Intelligence

• To stay updated on new regulatory guidelines circulars public notices and alerts issued through Health
• Authority websites and to circulate this information within the team for timely action.

Management of India PSUR submission

Prepare India specific PSURs based on the global PBRER

Submit the PSURs to Health Authorities within timeline

Responsible for responding to Health Authority Questions based on PSUR

Handling submission/review/query responses for commercial products including SEC preparation

Manages regulatory compliance including renewal/amendments minimum supervision from manager

Maintain complete documentation records and all trackers are timely maintained

Support relevant Audits internal and external Deviations & CAPA action

Support internal and external audits by ensuring all regulatory documents and processes are audit-ready and addressing audit requirements in a timely manner.

Assist in managing deviations and implementing CAPA actions ensuring compliance with regulatory standards and continuous process improvement.

Location : Mumbai

Education Qualifications Skills and Experience.

Essential:

• Degree or equivalent professional qualification in related field

Experience in quality assurance within a pharmaceutical manufacturing environment.

Desirable: Post-graduate qualification

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.

You can find alternative messaging to use in the Global Talent Attraction Story messaging section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates!

So whats next

• Are you already imagining yourself joining our team Good because we cant wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table Brilliant! We have one seat available and we hope its yours.

Where can I find out more

Our Social Media Follow AstraZeneca on LinkedIn AstraZeneca on Facebook AstraZeneca on Instagram you have site country or departmental social media then feel free to switch any of the above links.

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.