This listing was posted on ListedBuy.
Regulatory Affairs Manager
Location:
Maidenhead
Description:
Manager, Life Cycle Management This position is responsible for post approval changes of Marketing Authorisations, and product life cycle management. 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 backss the regulatory impact of change control/requests for the manufacturing, testing and release of drug substance and drug product. : Provide product and 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. : Shall participate in resource planning and recruitment procedure. : Ensure compliance with company policies, procedures and training expectations. : Performs other appropriate duties, where necessary Required Skills : understanding of GMP, Quality and. Visit ListedBuy for more information.
Posted:
April 23 on ListedBuy
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to ListedBuy
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Regulatory Affairs Manager
Regulatory Affairs Manager is a Other Art & Media Jobs Manager Job located in United States. Find other listings like Regulatory Affairs Manager by searching Oodle for Other Art & Media Jobs Manager Jobs.
Regulatory Affairs Manager is a Other Art & Media Jobs Manager Job located in United States. Find other listings like Regulatory Affairs Manager by searching Oodle for Other Art & Media Jobs Manager Jobs.