Regulatory Affairs Manager II

Job Description

Job Title: Regulatory Affairs Manager II (Packaging & Artwork)

Career Level: D Introduction to role:

Are you ready to lead the charge in transforming drug development strategies into reality? As a Regulatory Affairs Manager II, you'll be at the forefront of coordinating, developing, and implementing new and revised printed labeling for our commercial products. Your expertise will ensure that packaging components meet regulatory standards across the US, export markets, and EU centralized procedures. Dive into a role where your strategic input and leadership in cross-functional activities will drive continuous improvement in processes and tools.

Accountabilities:

What you'll do:

• Ensure all work is performed in accordance with established procedures, regulatory requirements, and GxPs.
• Serve as the point of contact for managing all labeling/artwork requests for allocated products requiring market/regulatory approval in the US, markets receiving a standard export pack, and EU centralized procedures.
• Coordinate and/or lead the development and lifetime maintenance of packaging component labeling for commercial products, including new pack introductions, product launches, updates to existing packs, and mock-ups for regulatory submissions.
• Collaborate with marketing company colleagues regarding global artworks as appropriate.
• Engage with operations/manufacturing sites regarding implementation of global artworks as needed.
• Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks, and other assigned labeling documents.
• Process and prepare all final printed labeling for the US and required EU specimens for submission.

Essential Skills/Experience:

• Relevant university degree in science or related discipline
• Minimum 7 years of regulatory experience within the biopharmaceutical industry, preferably working with labeling
• 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

Desirable Skills/Experience:

• Experience in packaging labeling development and/or maintenance
• Experience working with stakeholders from locations outside of India, especially Europe and/or USA

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, innovation drives us forward. We are committed to pushing beyond traditional regulatory approaches to develop progressive solutions that prevent and treat diseases. Our diverse team thrives on curiosity and collaboration, empowering us to make quick decisions and influence drug development strategies. With a focus on technology adoption and automation, we strive for efficiencies that bring life-changing medicines to patients faster. Here, you'll find a supportive environment where your professional growth is nurtured through our Regulatory academy and development path.

Ready to make an impact? Apply now to join our dynamic team and be part of shaping the future of medicine!

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.