About the Company
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. Operating in over 100 countries, we are committed to pushing the boundaries of science to deliver life-changing medicines to patients worldwide. Our UK operations are a crucial part of our global network, fostering innovation and contributing significantly to global health.
Job Description
We are seeking a dedicated and experienced Regulatory Affairs Manager to join our dynamic team in Southampton. This pivotal role involves managing regulatory submissions, strategies, and compliance for our pharmaceutical and medical device products across various international markets. You will be instrumental in navigating complex regulatory landscapes, ensuring timely approvals, and maintaining product lifecycles in accordance with global health authority requirements. This position offers international sponsorship for qualified candidates looking to make a significant impact within a leading biopharmaceutical organisation.
Key Responsibilities
- Develop and implement regulatory strategies for new product registrations and lifecycle maintenance across a portfolio of pharmaceutical and medical device products.
- Prepare, review, and submit high-quality regulatory dossiers (e.g., CTAs, MAAs, variations, renewals) to global health authorities, ensuring compliance with local and international regulations.
- Act as the primary regulatory contact for assigned projects, liaising effectively with cross-functional teams (R&D, Clinical, Manufacturing, Commercial) and external stakeholders.
- Monitor and interpret regulatory intelligence, assess its impact on company products, and communicate updates to relevant internal departments.
- Manage and resolve regulatory queries from health authorities, ensuring timely and appropriate responses.
- Lead and participate in regulatory agency meetings and interactions.
- Ensure all regulatory activities are conducted in accordance with company policies, standard operating procedures, and industry best practices.
- Provide strategic regulatory input into product development plans and portfolio management.
- Mentor and and guide junior regulatory affairs professionals within the team.
Required Skills
- Minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical or medical device industry.
- Proven track record of successful regulatory submissions and approvals (e.g., MAAs, NDAs, IDEs, 510(k)s).
- In-depth knowledge of global regulatory requirements (e.g., FDA, EMA, MHRA) and ICH guidelines.
- Excellent understanding of drug development processes and lifecycle management.
- Strong analytical, problem-solving, and decision-making abilities.
- Exceptional written and verbal communication skills in English.
- Ability to work independently and collaboratively in a fast-paced, international environment.
- Proficiency with electronic document management systems and eCTD submission software.
Preferred Qualifications
- Advanced degree (MSc, PhD, PharmD) in a life science, pharmacy, or related field.
- RAC (Regulatory Affairs Certification).
- Experience with biological products or advanced therapy medicinal products (ATMPs).
- Proficiency in additional languages relevant to key international markets.
- Experience in leading cross-functional regulatory projects.
Perks & Benefits
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holiday allowance.
- Competitive pension scheme.
- Opportunities for professional development and continuous learning.
- Employee assistance program.
- On-site fitness facilities and wellness programs.
- Subsidised cafeteria and free parking.
- International relocation support and visa sponsorship.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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