Achieva Group Limited: Regulatory Affairs Manager
join.com
Date: 2 weeks ago
City: St Albans
Contract type: Full time
Achieva Group Limited is looking for a Regulatory Affairs Manager
This position is responsible for post approval changes of Marketing Authorisations, and product life cycle management.
Tasks
Duties Inclusive But Not Limited To The Below
Required Skills:
This position is responsible for post approval changes of Marketing Authorisations, and product life cycle management.
Tasks
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.
- 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 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.
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Home Instead - St Albans: Personal Care Assistant
join.com,
St Albans
2 weeks ago
Home Instead - St Albans is looking for a Personal Care AssistantHome Instead St Albans Care Assistants are not just there to assist their clients in daily tasks, but more importantly to ensure that they have the ability to remain independent in their own homes for as long as possible.Our Care Assistants are valued for their personal skills and individuality...
Customer Assistant- Foods - London Colney
Marks and Spencer,
St Albans
3 weeks ago
SummaryCustomer Assistant- In Store Bakery - London ColneyWorking PatternMonday 0800-1600Tuesday 0800-1600Thursday 0800-1600Friday 0800-1600Saturday 0800-1600All the detailsCustomer Assistant- In Store Bakery - London Colney Due to the natures of the role candidates must be over 18Working PatternMonday 0800-1600Tuesday 0800-1600Thursday 0800-1600Friday 0800-1600Saturday 0800-1600Purpose To deliver a great shopping experience for our customers, we are looking for colleagues who put customers before tasks...
Aon Graduate Programme - Actuarial Consulting - Pensions (Regional Locations) 2025
Aon,
St Albans
3 weeks ago
Actuarial Consulting Pensions Graduate Progamme - (Regional Locations)Start Date: March 2025 or September 2025Application closing date: 2nd December 2024Better Decisions Begin with YouAt Aon, we shape decisions for the better to protect and enrich the lives of people around the world. As an organisation, we are united through trust as one inclusive, diverse team, and we are passionate about helping...
