Regulatory Affairs Consultant

Established in 2005, DLRC Ltd has developed a deserved reputation for being a leading consultancy, with a wealth of regulatory and scientific knowledge and considerable experience in both leadership and management. The company has recently expanded to include affiliates based in Germany and the US.

Our growing team comprises over 90 qualified professionals with a pharmaceutical and/or regulatory background, as well as over 30 dedicated supporting staff in areas of Business Development, Finance, Business Services and People Practices. We provide services to over 130 organisations, enabling them to achieve their strategic and operational development objectives.

DLRC's expertise and flexible working approach ensures the provision of a highly motivated team who interact effectively with clients and regulators globally, to support both single issues and long-term commitment to projects.

We are looking to expand our Regulatory Affairs team and are currently looking for an experienced Regulatory Consultant to join us on a one-year fixed contract or a permanent basis.

This position can be worked on hybrid basis or from our offices in Letchworth, UK.

The role

The Regulatory Consultant will be responsible for managing a portfolio of projects for a number of clients. This will include labelling management but may also encompass projects in clinical development, at MAA filing stage and post approval lifecycle management.

Responsibilities:
• Lead and support regulatory projects on behalf of the client including liaising and negotiation with regulatory authorities
• Manage and support regulatory procedures at both the national and EU level
• Manage and support US projects as required
• Prepare and oversee the development and maintenance of core data sheets, and core patient product information as well as local product labels throughout the product lifecycle
• Ensuring regulatory compliance as required
• Prepare regulatory submissions and agency interactions
• Provide regulatory strategic advice on guidelines, legislation and procedures to clients on assigned projects
• Analyse changes in the regulatory environment and legislation for impact on project/plans and the overall business
• Prepare and manage regulatory submissions and agency interactions
• Develop regulatory plans to meet project and client goals.

Required Experience:
• Educated to minimum BSc level within Life Sciences or Pharmacy.
• Previous experience working within Regulatory Affairs
• Previous experience of developing and maintaining global labelling content
• Good work ethic & strategic mindset
• Experience working with EU requirements, US highly advantageous
• Commitment to deliver client and company requirements by demonstrating a willingness to help others outside the individual responsibilities
• Analyse and understand current and future regulatory environment and its impact on assigned projects and apply to the business environment.

We are a forward-thinking regulatory affairs consultancy, DLRC Ltd takes the time to understand individual needs and find creative solutions for any regulatory challenge.

Selection of candidates & interviews will be conducted continuously so please submit your application as soon as possible.

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