Job title: Associate Regulatory Affairs Director I
Company: AstraZeneca
Job description: JOB TITLE : ASSOCIATE REGULATORY AFFAIRS DIRECTOR I
CAREER LEVEL: E
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 Associate Regulatory Affairs Director I in our packaging and artwork team is responsible for the process for coordination, development and implementation of new and revised printed labeling for assigned commercial products. Coordinates and leads the content development for packaging components and supports the labeling content development of US and EU centralised labeling.
The Associate Regulatory Affairs Director I is fully proficient in applying established standards. Performs packaging and artwork deliveries for moderately to highly complex products. May facilitate strategic input, capable of leading cross functional activities. Participates and if required leads 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 and EU centralized procedure, such as the creation, approval, and implementation of commercial printed labeling in collaboration with various functions.
Coordinate and 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
Training and mentoring junior colleagues
Participation in process improvement initiatives, representing the group in cross functional forums and leading product/process initiatives
Minimum Requirements –Education and Experience
Relevant University Degree in Science or related discipline
Around 9 years regulatory experience within the biopharmaceutical industry, preferably working with labelling implementation, artwork coordination etc
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
Operations/Manufacturing sites
Packaging coordinators
Artwork Studio
Marketing Companies/Local affiliates
Health Authorities
External collaboration partners
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
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.
Date Posted 08-Jun-2022
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.
Expected salary:
Location: Bangalore, Karnataka
Job date: Thu, 09 Jun 2022 23:40:24 GMT
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