Regulatory Affairs Specialist

SERB • Weybridge, VT

41d

About The Position

To be responsible for all aspects of regulatory affairs and regulatory compliance for the assigned Company’s licensed products as well as product development projects intended for inclusion into Marketing Authorisation Applications. This includes preparing and maintaining dossier documentation, licence variations and product information primarily in the UK and Europe.

Requirements

• Educated to degree or equivalent level in a life science or Medical subject.
• Prior experience of a Regulatory Affairs role with MAA and life-cycle management in the UK and/or Europe.
• Ability to prepare, review and maintain product information and CMC documentation.
• Experience of product development and new applications.
• Post marketing experience including variations, renewals and labelling.
• Ability to establish and maintain effective working relationships with internal and external stakeholders.
• Strong written and verbal communication skills.
• Clear and effective communication to colleagues and internal and external stakeholders.
• Collaborative working style with colleagues.
• Ensure the Company's regulatory interactions with Competent Authorities are of the highest calibre
• Must be self-motivated with the ability to handle multiple tasks simultaneously.
• Demonstrated advanced computer skills – Microsoft Office preferred.
• Demonstrated success working in a team environment.

Nice To Haves

• Preferably experience in writing / reviewing of MAAs and use of Regulatory information management databases (e.g. Veeva RIM).

Responsibilities

• Manage the preparation, collation and review the relevant information for timely submission to Regulatory Authorities in accordance with local requirements.
• Manage the evaluation of the regulatory impact of post-marketing activities such as projects or proposed manufacturing changes and to ensure continued compliance with regulatory licences.
• Represent the Regulatory function on multi-disciplinary teams for licensed products with regard to projects and proposed post-marketing changes. Ensure that the regulatory strategy is aligned with project and business objectives and that deliverables are on time.
• Manage the preparation and maintenance of submission documents in support of licensed products (e.g. variations, annual reports, meeting requests, general correspondence, responses to inquiries from regulatory agencies). Involves the collection, review and assembly of scientific, medical, manufacturing, and other supporting documentation into submission documents.
• Manage UK & EU  submission tracking and document control activities, including data entry in relevant systems to ensure data is kept up to date.
• Contribute to the authoring and maintenance of Company regulatory procedures and processes including creation and maintenance of Company Core Data Sheets (CCDS).
• Represent the Regulatory function at Change Control Review and CAPA Boards as required.
• Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with SERB values
• Carry out other reasonable tasks as required by the Line Manager.

Benefits

• competitive compensation & benefit packages
• challenging opportunities
• a culture of working together in a supportive way built on our strong foundation of values

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees