Job Title: Associate Regulatory Affairs Director I
Global Career Level: E
Introduction to role
The Associate Regulatory Affairs Director I is a regulatory affairs professional responsible for coordinating, developing, and implementing new and revised printed labelling for assigned commercial products. This role involves managing the content development for packaging components and supporting the labelling content development for US, export packs, and EU centralised labelling. You will perform packaging and artwork/standard export activities for moderately to highly complex products independently and may provide strategic input capable of leading cross-functional activities and cross-project activities. Additionally, you will mentor junior staff and lead continuous improvement of processes and tools/systems.
Accountabilities
Ensures all work is performed in accordance with established procedures, regulatory requirements, and GxPs.
Acts as the point of contact for managing all labelling/artwork requests for allocated products requiring market/regulatory approval in the US, markets receiving a standard export pack, and EU centralized procedure.
Coordinates and/or leads the development and lifetime maintenance of packaging component labelling for commercial products, including new packs, product launches, updates to existing packs, and mock-ups for regulatory submissions.
Provides tactical and strategic guidance to product labelling teams regarding regulatory requirements for packaging component labelling.
Interacts with marketing company colleagues regarding global artworks, as appropriate.
Interacts with operations/manufacturing sites regarding the implementation of global artworks, as appropriate.
Ensures proper version control and document integrity of packaging component labelling, printed labelling artworks, and other assigned labelling documents.
Processes and prepares all final printed labelling for the US and the required EU specimens for submission.
Participates in the development and maintenance of work practices, templates, and associated documents relating to the labelling function.
Liaises with relevant stakeholders as needed to resolve critical labelling issues.
Represents functional expertise at relevant department meetings and relevant cross-functional subteams.
Essential Skills/Experience
Relevant university degree or equivalent experience in science or related field
Minimum 10 years of regulatory experience within the biopharmaceutical industry, preferably working with labelling
Keen attention to detail and accuracy
Thorough knowledge of labelling regulations and guidance
Strong project management skills
Leadership skills, including experience leading multi-disciplinary project teams
Experience in packaging labelling development and/or maintenance
Experience collaborating with partners from locations outside of India, especially Europe and/or USA
Excellent written and verbal communication skills in English
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
Focus on continuous improvement and knowledge sharing
Internal and External Contacts/Customers
Global Labelling Group
Operations/manufacturing sites
Packaging coordinators
Artwork studio
Marketing companies/local affiliates
Health authorities
External collaboration partners.
Reporting Relationship
Direct Reports – None
Indirect Reports – None.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We thrive in an inclusive, diverse, and bold environment where we draw on our diverse knowledge to take smart risks and uncover new ways to deliver better outcomes for our patients and business. Our rich pipeline provides exposure to the complete drug delivery process and opportunities to take on new challenges.
Ready to make a difference? Apply now!
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.