Regulatory Compliance Executive

Overall purpose of role:

Assist in maintaining the regulatory compliance of the companies Marketing Authorisations for all marketed and non-marketed products in all markets.

Assist in the review and management of Regulatory Compliance strategies in conjunction with colleagues, local regulatory partners and third party organisations.

Assist in the review and management of Change Control procedure within Regulatory department, making proposals for system enhancement whenever appropriate.

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 in-line activities.

Carry out the day-to-day activities of the Regulatory Compliance team.

This position reports to the Regulatory Compliance Lead / Manager

Summary of Tasks & Responsibilities:

General

• Assist in the development and implementation of SOPs on Regulatory Compliance systems.
• Reviewing relevant Regulatory, Quality, Technical and Medical documents to ensure they are in compliance with SOPs and Marketing Authorisations (MAs) where the company is the MA holder.
• Ensuring local regulatory partners and distributors carryout required MA regulatory compliance checks and have the necessary systems and procedures in place.
• Carrying out regulatory compliance checks on post-MA transfer MAs for newly acquired products.
• Ensuring newly granted MAs (obtained via MA Application) are set up on the MA compliance system and then monitored.
• Carrying out Regulatory Compliance audits within the company and third parties where necessary.
• To provide regulatory conformance support to site’s Quality, Product Manufacturing, Medical and other stakeholder groups.
• To ensure all applicable regulatory information is reviewed, stored securely and that databases, Spreadsheets, and Trackers are monitored and maintained.
• Providing key inputs to inter-departmental Change Control meetings.
• To work in accordance with company policies and standard procedures.
• To manage all tasks, meeting due dates and ensure adequate records are maintained.
• To support Site and Regulatory Compliance inspections and audits and assist in ensuring compliance with Regulatory legislation.
• Review and assist in the maintenance and monitoring of the Regulatory License Master database and ensure that all Company departments are aware and trained appropriately.
• Where the position involves direct supervision of reports or teams to provide support,supervision, coaching and training.
• Support that the regulatory compliance strategy defined by the Head of Regulatory Operations is implemented correctly and on time.
• Assist in the communication with all relevant or specified Third Party Manufacturers and API suppliers as required on behalf of the department.
• Review and assist in the archiving and filing of documents in the department to ensure relevant SOPs are adhered to.
• Review Change Control procedures within Regulatory department, making proposals for system enhancement whenever appropriate.

Regulatory Partners

• 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.
• Develop and maintain a regulatory compliance strategy for regulatory partners. Ensure that regulatory partners are aware and informed of company SOPs regarding any filing or record keeping.

Team

• Provide advice, guidance and development to members of the Regulatory Compliance Team; delegating work as appropriate, setting objectives, monitoring and managing performance.

Others

• Plan, and execute the routine regulatory compliance tasks associated with the products held in all markets. These include but are not limited to MPSs, MMSs, Renewals and other regulatory requests as required.
• Prepare monthly reports for the Head of Regulatory Operations, as defined in the company procedures or as required.

Personal Attributes

Qualifications & Experience:

• Essential: Degree in Chemistry, Pharmacy or allied subject
• Essential in: Min 1-3 years experience in Regulatory Affairs, Regulatory Compliance, Quality Assurance or equivalent in the Pharmaceuticals industry.
• Ideal in: Previously worked in Generics Manufacturing, QC, QA or Regulatory Compliance specialising in CMC.
• Project management.
• All round experience in regulatory procedures.
• Competent user of MS Word, Excel, Outlook, MS Project, etc.
• Manufacturing site audits
• Development or manufacture of a variety of pharmaceutical dosage forms.
• Active pharmaceutical ingredient manufacture.
• Pharmaceutical product analysis.
• Analytical method development.

Even if you are unsure on your suitability for this position but you are looking at the possibility of some progression in your current job or a change in your career path, please feel free to contact me for a friendly chat to explore any options that may be open to you.

All enquiries will be dealt with in a strictly confidential manner. Call Matt on 01293 776644 or email me at mhart@barringtonjames.com