Senior Regulatory Affairs Specialist

3 weeks ago


St Albans, Hertfordshire, United Kingdom Achieva Group Limited Full time

This role is pivotal in overseeing the modifications of Marketing Authorisations following approval, alongside managing the product life cycle effectively.

Key Responsibilities

Core duties include but are not limited to:

  • Responsible for the oversight of post-approval submissions and life cycle maintenance of Marketing Authorisations, including variations, notifications, labelling updates, renewals, and sunset clauses across the product range.
  • Management of MIA and WDA, including the registration of API imports.
  • Developing filing strategies and ensuring adherence to submission timelines.
  • Identifying and addressing any compliance deficiencies.
  • Collecting, consolidating, and analyzing documentation for regulatory submissions.
  • Coordinating and drafting responses to inquiries from regulatory bodies.
  • Tracking the progress of regulatory applications.
  • Evaluating the regulatory implications of change control requests related to the manufacturing, testing, and release of drug substances and products.
  • Offering product and regulatory expertise, clarifying RA requirements for post-marketing modifications and new product launches.
  • Providing regulatory assistance to supply chain, commercial teams, QP, QPPV, and Quality 3rd Party contract management as required.
  • Contributing to the development, maintenance, and enhancement of Regulatory processes, policies, and systems.
  • Keeping abreast of Regulatory and Quality Management requirements to support the contract manufacturing of existing products and the launch of new offerings.
  • Fostering strong working relationships with CMOs and cross-functional teams within the organization.
  • Supervising team members in terms of management and training.
  • Participating in resource planning and recruitment activities.
  • Ensuring adherence to company policies, procedures, and training standards.
  • Performing additional relevant duties as necessary.
Qualifications

Essential Skills:

  • Comprehensive understanding of GMP, Quality, and Regulatory standards.
  • Strong communication skills, capable of engaging with various stakeholders at all levels, both internally and externally.
  • Expertise in the preparation and compilation of eCTD submissions, including eCTD validation and viewing tools.
  • Maintaining an up-to-date awareness of evolving regulatory requirements.


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