Senior Regulatory Affairs Specialist
3 weeks ago
This role is pivotal in overseeing post-approval modifications of Marketing Authorisations and managing the product lifecycle effectively.
Key ResponsibilitiesThe following duties are essential to this position:
- Responsible for the oversight of post-approval submissions and lifecycle maintenance of Marketing Authorisations, including variations, notifications, labelling updates, renewals, and sunset clauses across the product range.
- Management of MIA and WDA, ensuring compliance with API import registration.
- Developing filing strategies and managing submission timelines efficiently.
- 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 guidance to supply chain, commercial teams, QP, QPPV, and Quality 3rd Party contract management as required.
- Contributing to the development, maintenance, and ongoing 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 introduction 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 expectations.
- Performing other relevant duties as necessary.
Essential Skills:
- Comprehensive understanding of GMP, Quality, and Regulatory standards.
- Strong communication skills with the ability to engage a diverse range of stakeholders, both internally and externally.
- Expertise in the publishing and compilation of eCTD submissions, including eCTD validation and viewing tools.
- Awareness of evolving regulatory requirements.
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