Packaging & Artwork Manager

JOB TITLE :  PACKAGING & ARTWORK MANAGER

CAREER LEVEL: D

Lead the way for a new breed of solutions-oriented Regulators

Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development

Be part of the team where you are empowered to follow the science

Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals..

About 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. Always committed to lifelong learning, growth and development

About the team

We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.

About the role

The Regulatory Affairs Manager I/II is responsible towards the regulatory role as part of the process for coordination, development and implementation of new and revised printed labeling for assigned commercial products for US, EU centralised labeling and for  international shared packs. The Regulatory Affairs Manager I/II coordinates the content development for packaging components and supports the labeling content development of US, EU centralised labeling or labeling for international shared packs.

The Regulatory Affairs Manager I/II is fully proficient in applying established standards. Performs packaging and artwork deliveries for moderately complex products. Participates in continuous improvement of process and tools/systems.

Typical Accountabilities

• Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.

• Point of contact for the management of all labelling/artwork requests for allocated products that require market/regulatory approval in US, EU centralized procedure and for international shared packs, such as the creation, approval, and implementation of commercial printed labeling in collaboration with various functions.

• Coordinate and/or lead the development and lifetime maintenance of packaging component labeling for commercial products, including introduction of new packs and new product launches, updates to exisiting packs and mock-ups for regulatory submissions

• Interact with Marketing Company colleagues regarding global artworks as appropriate

• Interact with Operations/manufacturing sites regarding implemention of global artworks as appropriate

• Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks and other assigned labeling documents

• Process and prepare all US Final Printed Labeling and required EU specimens for submission and for international shared packs

Minimum Requirements –Education and Experience

• Relevant University Degree in Science or related discipline

• Around 6-11 years regulatory experience within the biopharmaceutical industry, preferably working with implementation of updated label components

• Keen attention to detail and accuracy

• Thorough knowledge of labeling regulations and guidance

• Strong project management skills

• Leadership skills, including experience leading multi-disciplinary project teams

Preferred Experience

• Experinece in packaging labeling development and/or maintenance

• Experience of working with stakeholders from locations outside of India, especially Europe and/or USA

Skills and Capabilities

• Excellent English written and verbal communication skills

• Cultural awareness

• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions

• Proficiency with common artwork management tools, document management systems, SharePoint etc

• Ability to work independently and as part of a team 

• Influencing and stakeholder management skills

• Ability to analyze problems and recommend actions

• Continuous Improvement and knowledge sharing focused

Internal and External Contacts/Customers

• Global Labelling Group

• Regulatory Affairs Managers

• Operations/Manufacturing sites

• Packaging coordinators

• Artwork Studio

• Marketing Companies/Local affiliates

• Health Authorities

• External collaboration partners

Reporting Relationship

• Direct Reports - None

• Indirect Reports -None

WHY JOIN US ?

We believe there’s always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals.

Our advanced approach to Regulatory means we are leading the field. We get to work closely with drug development to influence early on and continue to add value throughout

SO, WHAT’S NEXT?

Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

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 authorisation and employment eligibility verification requirements.