Jan 27, 2023
United Kingdom

Job Description

500 million+, this is the number of patients treated with a Sandoz medicine globally. A division of Novartis, Sandoz is a global leader in generic and biosimilar medicines. We are now hiring a Supply Chain Management Specialist to join our Supply Chain Management team.

The Regulatory Affairs Executive will be responsible for the performance of various regulatory activities. Ensuring timely, accurate and strategic preparation and submission of registration dossiers to obtain and launch new UK Marketing Authorisations whilst also supporting business needs such as re-introductions and portfolio expansion projects.

Your responsibilities:

Your responsibilities include, but are not limited to:
• The execution of business aligned regulatory filing strategies in collaboration with regional and local stakeholders to meet the product launch deadline.
• Preparation and submission of New Marketing authorisation application (National/DCP/MRP/CP); Product launch limiting MA variation; Change of ownership applications; Educational materials and associated risk minimisation measures
• Timely execution of launch enabling regulatory activities such as the registration of Risk Management Plans and associated educational materials, the registration and sign off artworks, approval of launch limiting variations.
• Engagement with the MHRA to address application queries, liaising with relevant company departments and external sources to ensure full and rapid responses.
• Liaising with customers and third-party suppliers concerning regulatory activities such as own label supplier registration, ongoing maintenance, and change of ownerships, to ensure compliance is maintained whilst meeting customer expectations.
• Liaising with launch team to input the progress of regulatory application and/ or projects to assist with mapping out product launch activities.
• Handling the regulatory activities in relation to the re-introduction of license and coordination with other stakeholder to ensure execution of regulatory strategy in this regard.
• Carrying out other activities which contribute to the effective performance of the Regulatory Affairs Department.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• BSc in Life Sciences
• Experience (2 to 3 years) in Regulatory Affairs within a Generic or Pharma business.
• Experience in supporting new product launch activities including labelling, artwork, and educational materials.
• Experience in working with new product registration particularly the MHRA.

Desirable requirements:
• Experience in project management.
• Experience in working with various variation applications prior to product launch.
• Ability to be flexible and multi-task within a fast-paced environment.

You’ll receive:

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 24 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why consider Sandoz? 

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world? 

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks. 

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics. 

Imagine what you could do at Sandoz!  

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

We are Sandoz, a Novartis Division. Join us and help reimagine medicine.

United Kingdom
Research & Development
Full Time
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Regulatory Affairs Executive - Launches & Projects

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