Job Description
bout 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 world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Position purpose
1) Artwork Management (all components) Understanding and operational efficiency of artwork management system. · Artwork requests to be raised with India specific annotations. · Comments received from overseas sites to be addressed and post peer review, approve final artwork files as per artwork approval checklist. Coordination with packaging coordinator, supply chain, BU/ Pricing / Legal team wherever required.
2) Support for QR code / serialization implementation as per business and regulatory needs.
3) Review and impact assessment of new India regulations relevant to labels if any. Ensure implementation as per timelines in coordination with local/ global stakeholders.
4) Support artwork developed for local partners as applicable.
5) Support labels of neighbouring markets e.g. Nepal as needed.
6) Prepare for audit of labeling activity if any and implement CAPAs if applicable.
7) Liaison closely with overseas manufacturing site for labels of 1st launch batch, exploring innovative options for early launch.
8) Ensure 100% adherence to internal and external labelling requirements.
Internal customers
Marketing, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams (GPTs), Key Brand Teams (KBTs), International Regulatory Affairs (IRA), Manufacturing Sites and QA
External customers Local Health Authorities and other Government Agencies
Minimum requirements Qualification: B. Pharm/ M. Sc 3-6 yrs Experience in India Artwork requirement and knowledge of D&C act for Artwork checklist. Should be conversant with Indian regulations in Artwork development.
Key Result Areas/ outputs ·
Adherence to AZ and industry codes of conduct, ethics and good regulatory practices ·
Ensure that all artwork request for assigned products is complete in accordance with relevant norms ·
Develop and implement action for Artwork development for allocated products to achieve requisite approvals rapidly and facilitate the rapid implementation · Evaluates impact of new artwork guidelines in liaison with RA leadership
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
Ensure that all artwork request for assigned products is complete in accordance with relevant norms.
Monitor status of all product artwork request · Manage revision in product artworks and coordinate with other changes, planned and in progress · Maintain complete documentation records and all trackers timely maintained
Develop and implement Action for Artwork development for allocated products to achieve requisite approvals rapidly and facilitate the rapid implementation.
Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, , regulatory timelines and supply strategy and proactive preparation of required steps · Implement artwork development plan for new launches in conjunction with key stakeholders and deliver plans on time. Track status and take prompt corrective measures whenever necessary to ensure rapid approval of artwork.
Team player, collaboration · Collaborates with cross functional teams- Supply chain, QA, medical, access as needed and with regional/ international RA colleagues · Good team player · Demonstrates ownership and accountability of assigned project with independent handling of projects with minimum supervision from manager/ lead.
Regulatory Compliance and life cycle maintenance · Ensure timely development and approvals of artwork along with compliances as per external and internal norms with minimum supervision from manager and internal databases · Support relevant audits internal and external · Supports deviations/ CAPA as needed for artwork deviations
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.
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, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t 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 it’s yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Retur
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 world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.
Position purpose
1) Artwork Management (all components) Understanding and operational efficiency of artwork management system. · Artwork requests to be raised with India specific annotations. · Comments received from overseas sites to be addressed and post peer review, approve final artwork files as per artwork approval checklist. Coordination with packaging coordinator, supply chain, BU/ Pricing / Legal team wherever required.
2) Support for QR code / serialization implementation as per business and regulatory needs.
3) Review and impact assessment of new India regulations relevant to labels if any. Ensure implementation as per timelines in coordination with local/ global stakeholders.
4) Support artwork developed for local partners as applicable.
5) Support labels of neighbouring markets e.g. Nepal as needed.
6) Prepare for audit of labeling activity if any and implement CAPAs if applicable.
7) Liaison closely with overseas manufacturing site for labels of 1st launch batch, exploring innovative options for early launch.
8) Ensure 100% adherence to internal and external labelling requirements.
Internal customers
Marketing, Logistics, Medical, Legal Affairs Intellectual Property, Global Product Teams (GPTs), Key Brand Teams (KBTs), International Regulatory Affairs (IRA), Manufacturing Sites and QA
External customers Local Health Authorities and other Government Agencies
Minimum requirements Qualification: B. Pharm/ M. Sc 3-6 yrs Experience in India Artwork requirement and knowledge of D&C act for Artwork checklist. Should be conversant with Indian regulations in Artwork development.
Key Result Areas/ outputs ·
Adherence to AZ and industry codes of conduct, ethics and good regulatory practices ·
Ensure that all artwork request for assigned products is complete in accordance with relevant norms ·
Develop and implement action for Artwork development for allocated products to achieve requisite approvals rapidly and facilitate the rapid implementation · Evaluates impact of new artwork guidelines in liaison with RA leadership
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
Ensure that all artwork request for assigned products is complete in accordance with relevant norms.
Monitor status of all product artwork request · Manage revision in product artworks and coordinate with other changes, planned and in progress · Maintain complete documentation records and all trackers timely maintained
Develop and implement Action for Artwork development for allocated products to achieve requisite approvals rapidly and facilitate the rapid implementation.
Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, , regulatory timelines and supply strategy and proactive preparation of required steps · Implement artwork development plan for new launches in conjunction with key stakeholders and deliver plans on time. Track status and take prompt corrective measures whenever necessary to ensure rapid approval of artwork.
Team player, collaboration · Collaborates with cross functional teams- Supply chain, QA, medical, access as needed and with regional/ international RA colleagues · Good team player · Demonstrates ownership and accountability of assigned project with independent handling of projects with minimum supervision from manager/ lead.
Regulatory Compliance and life cycle maintenance · Ensure timely development and approvals of artwork along with compliances as per external and internal norms with minimum supervision from manager and internal databases · Support relevant audits internal and external · Supports deviations/ CAPA as needed for artwork deviations
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.
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, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t 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 it’s yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Retur
💡 Quick Summary
Seeking a career-building opportunity? The Assistant Manager-Regulatory Affairs (Artwork & Packaging) position is now open for candidates interested in the Helper Jobs sector. This role in Mumbai offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Helper Jobs is a plus.