To apply for this International CMC regulatory affairs executive please call Julie Cooper on 020 8305 9733 or 07951 082482
Alternatively please send your CV to:
International Regulatory Affairs Executive
Head of Regulatory Operation
Overall purpose of role:
To provide post marketing approval (Chemistry, Manufacturing and Controls) CMC & Artwork and labelling regulatory and registration support for all products marketed and non-marketed products in the International countries assigned.
This position reports to the Head of Regulatory Operations.
Responsible for maintaining the regulatory compliance of Marketing Authorisations for marketed and non-marketed products sold in the countries assigned .
To collate and maintain all documentation required to support the Marketing Authorisations in countries assigned. Specifically CMC and new and existing Artwork and labelling.
To co-ordinate and manage the activities of the regulatory partners.
To act as a regulatory expert for assigned markets. To provide Regulatory guidance to Operations, International Business, Medical and Quality, assess impact of changes to the products, packaging, manufacturing, testing and stability. To give support at all levels within the department.
Liaise with all the relevant departments to ‘ensure the effective’ execution of the business in relation to the compliance life cycle of product licenses including acquisition, divestment, and ongoing inline activities and aligned with regulatory legislation.
There maybe a requirement to coach or supervise other team members.
Manage and execute regulatory projects, MA transfers, Technical Transfers., variations, renewals, PSURs.
To provide support to the Implementation Department in terms of product acquisitions and transitions.
Summary of Tasks & Responsibilities:
- Responsible to ensure that the regulatory strategy defined by the Head of Regulatory Operation for the countries assigned is implemented correctly.
- Liaise with the other members of the Regulatory team to gather and report Key Performance Indicators e.g. data and to develop plans and actions to improve performance.
- Liaise with the other Regulatory team members and other functions to manage the priorities of compliance changes and regulatory work so that it meets the business objectives
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- Participate and/or manage designated regulatory projects, setting up project plans to ensure that regulatory approvals are delivered and can be implemented on time.
- Build and maintain local, central and external relationships in order to influence the regulatory environment.
- Support the Head of Regulatory Operation to identify, select and recommend suitable regulatory partners to provide support in the relevant territories.
- Monitor, manage and report on the relationship of the regulatory partners and where necessary take and/or recommend effective actions to improve both the relationship and performance.
- Support the Head of Regulatory Operation in the review, analysis and development of effective company policies and procedures.
- Develop and maintain a detailed plan of all known regulatory activities for the countries assigned. Where necessary highlight and justify the need for additional resources.
- Process all Marketing Authorisations and Variation applications on a timely basis and ensures that all, responses to regulatory questions are undertaken on a timely basis in line with the defined and agreed targets.
- Follow all company policies and procedures business, GxP and legislation.
- Assist the Head of Regulatory Operation in identifying the regulatory requirements of new acquisitions.
- Assist with due diligence activities for potential in-licensing opportunities for brand and generic products, and evaluate dossiers.
- Plan, and execute the routine regulatory compliance tasks associated with the products held in the countries assigned. These include but are not limited to PSURs, Safety Updates, Renewals, other regulatory requests as required.
- Review all relevant data and documents from the different departments and/or third parties involved for eligibility and consistency throughout the MAA. For the countries assigned.
- Preparation of core CTD dossier for submission throughout the territories.
- Prepare monthly reports for the Head of Regulatory Operation, as defined in the company procedures or as required.
Support and assist in managing Site and Regulatory inspections.
- Optimise the use of resources at all times.
- Assist in the training of new and existing artwork and regulatory personnel.
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- Provide monthly reports to the Head of Regulatory Operation.
- To perform any reasonable duties as requested by in line managers
- To undergo training to ensure skills are current
- Essential: Degree in Chemistry, Pharmacy or allied subject
- Ideal: Higher degree in Chemistry, Pharmacy or allied subject.
- Essential: Min 1-3 years experience in Regulatory Affairs or equivalent in the Pharmaceuticals industry.
- Ideal: Previously worked in Manufacturing, QC, QA or Regulatory Compliance.
All round experience in regulatory procedures.
Competent user of MS Word, Excel, Outlook, MS Project, etc.
(3) Personal qualities:
Detailed and process driven.
Good interpersonal communications, organizational, and presentation skills.
Able to supervise staff and teams.
Able to work with personnel of all levels within the organisation and with Third party companies.
Ability to work under pressure and achieve agreed timelines.
Able to keep focus, while managing multiple projects.
Key skills / key skill:
regulatory affairs executive , reg affairs , CMC , CMC , QC , QA Essex , International , executive , CMC , CMC
- 9 months ago