Job Description

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

\xc2\xb7 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.

\xc2\xb7 Maintenance of MIA and WDA including API import registration.

\xc2\xb7 Filing strategy and managing submission timelines.

\xc2\xb7 Identifying and remediating compliance gaps if any.

\xc2\xb7 Gather, consolidate, analyse documentation and submit regulatory filings.

\xc2\xb7 Coordinate and prepare written responses to requests for information from

regulatory authorities.

\xc2\xb7 Monitor status of regulatory applications.

\xc2\xb7 Review and assess the regulatory impact of change control/requests for the

manufacturing, testing and release of drug substance and drug product.

\xc2\xb7 Provide product & regulatory expertise and clarification on RA

requirements for post marketing changes and new product introduction.

\xc2\xb7 Provide regulatory support to supply chain, commercial teams, QP, QPPV,

Quality 3rd Party contract management as necessary.

\xc2\xb7 Contribute to the creation, maintenance and continuous improvement of

Regulatory processes, policies and systems.

\xc2\xb7 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.

\xc2\xb7 Build good working relationship with CMOs and cross functional teams

within the organisation.

\xc2\xb7 Supervise assigned team members with respect to management and

training.

Required Skills

\xc2\xb7 Understanding of GMP, Quality and Regulatory requirements.

\xc2\xb7 Communicative and able to work with a range of stakeholders, at all levels, both internally and externally. \xc2\xb7 Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools.

\xc2\xb7 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.

Cpl Group