Regulatory Affairs Executive in Bracknell

The performance of various regulatory activities to ensure 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 Key Responsibilities:

• 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 applications (National/DCP/MRP/CP), MA variation, Change of ownership applications and 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.
• Creation, assessment and approval of artwork texts and mock-ups.
• License cancellations.
• Sunset Clause monitoring and reporting.
• 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 stakeholders to ensure execution of regulatory strategy in this regard.
• Handling labelling changes and associated regulatory applications (e.g. PIQ) as per business or external needs.
• Ensuring timely response to Corrective and Preventative Actions (CAPAs) assigned to DRA and other associated quality management activities.
• Working in accordance with Global and local Working Instructions, SOPs whilst adhering to compliance.
• Maintenance of regulatory archives and record keeping.
• Reviewing and updating Summaries of Product Characteristics.
• The processing and clear communication of regulatory approvals to internal and external stakeholders within set timelines.
• Provision of regulatory support for medical information and patient safety to assist with queries on product information.
• Provision of regulatory support for strategic commercial opportunities.
• Provision of regulatory support for internal and external audits.
• Carrying out other activities which contribute to the effective performance of the Regulatory Affairs Department.

What you’ll bring to the role:

Essential Requirements:

• Experience (2 to 3 years) in Regulatory Affairs within a Generic or Pharma business.
• Experience in supporting new product launch activities.
• Ability to be flexible and multi-task within a fast-paced environment.

Desirable Requirements:

• Experience in working with new product registration & CMC elements of a dossier.
• Experience in project management.
• Experience in working with various variation applications.

You’ll receive:

• Competitive salary
• Annual bonus
• Pension scheme
• Health insurance
• 24 days annual leave
• Flexible working arrangements
• Employee recognition scheme
• Learning and development opportunities.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! Join us, help us make healthcare fairer and faster.

Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired: Analytical Skill, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance