Overview

Reference Number: JO-2311-526403
Regulatory Affairs Executive
Rate: Negotiable
Job Type: Permanent
Location: Maidenhead

Regulatory Affairs Executive

Salary: 35k-40k

Location: Maidenhead

Flexibility: Onsite 5 days a week

Cpl Life Sciences 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.

paul.adeyemi@cpl.com

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