Regulatory Affairs Executive
Salary: 35k-40k
Location: Maidenhead
Flexibility: Onsite 5 days a week
CPL are working with a generic manufacturing business that specialise in single oral dosage products. With the business looking to expand their team, they are looking for an individual who has Post Approval and UK/IR and EU experience. A successful candidate would support and answer to a Lead Auditor. Listed below are some key details of what the role would entail on a day to day basis.
Responsibilities:
Duties inclusive but not limited to the below
· Accountable for management of post-approval filings and life cycle
maintenance supplements of Marketing Authorisations like variations,
notifications, labelling updates, renewals, sunset clause etc across product
portfolio.
· Maintenance of MIA and WDA including API import registration.
· Filing strategy and managing submission timelines.
· Identifying and remediating compliance gaps if any.
· Gather, consolidate, analyse documentation and submit regulatory filings.
· Coordinate and prepare written responses to requests for information from
regulatory authorities.
· Monitor status of regulatory applications.
· Review and assess the regulatory impact of change control/requests for the
manufacturing, testing and release of drug substance and drug product.
· Provide product & regulatory expertise and clarification on RA
requirements for post marketing changes and new product introduction.
· Provide regulatory support to supply chain, commercial teams, QP, QPPV,
Quality 3rd Party contract management as necessary.
· Contribute to the creation, maintenance and continuous improvement of
Regulatory processes, policies and systems.
· Maintain up to date knowledge of Regulatory and Quality Management
requirements, as needed to support the contract manufacture of current
products and the introduction of new products.
· Build good working relationship with CMOs and cross functional teams
within the organisation.
· Supervise assigned team members with respect to management and
training.
Required Skills
· Understanding of GMP, Quality and Regulatory requirements.
· Communicative and able to work with a range of stakeholders, at all levels, both internally and externally. · Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools.
· Maintaining an awareness changing regulatory requirements.
Key Requirements
. UK/IR and EU affiliate experience
. Post Approval experience
. LCM experience
If you believe this role would be suitable and of interest, please feel free to reach out to me via email.