Job Title: Regulatory Affairs Manager
Introduction to role:
A Regulatory Affairs Manager ensures products meet regulatory requirements throughout their lifecycle, overseeing submissions, approvals, and compliance. Acting as a key link between the company and health authorities, they drive product registration, market access, and ongoing regulatory adherence.
Accountabilities:
We are looking for a proactive and detail-oriented professional to join our team, taking ownership of regulatory activities to ensure compliance and support business goals. Key responsibilities include preparing, submitting, and following up on marketing authorization applications, maintaining authorized products through timely variations and renewals, and ensuring accurate labeling translations and artwork. The role also involves recommending regulatory-compliant changes, monitoring control systems, maintaining product databases, and ensuring proper archiving of documentation in line with internal standards. You will foster a collaborative culture by sharing best practices, addressing regulatory authority queries, and building strong relationships with external stakeholders. Additionally, you’ll ensure compliance with global and local SOPs and regulatory requirements, adhere to GRP KPIs, identify risks, and complete required training for new procedures, contributing to continuous process improvement.
Essential Skills/Experience:
- Bachelor's degree in Pharmacy
- Strong experience in Regulatory Affairs in a Multinational Company
- Deep understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment
- Expert of drug development practice, rules, regulations and guidelines
- Networking internally and externally to learn in advance about new trends or changes impacting the Regulatory, Medical and overall Business strategy
- Team player, capable of effectively collaborating with the cross functional team
- Strong organizational skills
Desirable Skills/Experience:
- Advanced degree is a "Plus"
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines is desirable
At AstraZeneca, we are driven by our unwavering belief in the power of our medicines and the science behind them. Our team is fundamental in realizing the potential of our life-changing medicines by ensuring the right access is provided to patients. We thrive on co-creation, drawing on different minds and perspectives to pioneer Market Access innovations. Our dynamic environment keeps us motivated and inspired as we work towards faster and better access to improve patient outcomes. Join us to be part of a brave and imaginative team that takes smart risks and follows the science as guardrails.
Ready to make a difference? Apply now!
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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.