Regulatory Project Manager - OTC

My client are seeking a Regulatory Project Manager to play a key role in providing regulatory support for their UK & Ireland portfolio.

This role reports directly to the head of department, and will have full operational responsibility, as well as strategy responsibility on projects, and mentorship of junior team members. The plan is that this person will develop to take on more managerial role over time. It's a great chance for an ambitious person to really make their mark!

The portfolio is OTC medicines and devices, and the role works closely with the Marketing and Commercial teams to ensure complaint submissions and variations.

Main Responsibilities:

Portfolio Maintenance-

To maintain compliance with regulatory requirements, recommend and devise regulatory strategy, prepare and submit extension applications, variation applications and submissions.

In collaboration with Regulatory Assistant, ensure that renewal applications and PSURs are prepared and submitted to meet statutory time frames

Complete review of Product Quality Reviews in accordance with regulatory requirements and internal process

Responsibility for maintain product information (label and leaflet), SmPC, VMS review sheets and cosmetic PIF within agreed portfolio

New Product Development-

To contribute to the development process by identifying, then recommending strategy for local projects in order to get new products on to the market in the shortest time

To coordinate the preparation of submissions (e.g. marketing authorisation applications (MAA), switch applications, variations) with internal Partners as appropriate, e.g. Marketing, International Regulatory Affairs, R&D and local Quality functions

Support preparation for Health Authority scientific advice meetings when required

Submit MAAs to Health Authority ensuring agreed timeframes are met and all components of submissions meet agreed internal quality standards.

Communicate with Regulatory Authorities on the status of applications and respond to requests for further information

Development of the regulatory strategy and data requirements for global projects where UK or Malta are featured as target markets

Provide regulatory support in the preparation of health authority scientific advice meetings

Regulatory Intelligence-

Keep abreast of national and European regulatory requirements relating to the portfolio  

Review the external regulatory environment and share intelligence with relevant internal parties

Other-

To represent Company interests at local OTC trade association on assigned task forces

Create and maintain assigned UK Regulatory standard operating procedures

Qualifications, Experience and Skills:

• Degree or equivalent in life sciences, chemistry or pharmacy
• Sound knowledge of European regulatory requirements and specifically the UK regulatory environment
• Experience in Regulatory Affairs, with experience in managing projects
• Demonstrable ability to prepare high quality regulatory submissions
• Ability to communicate effectively and assertively with sound negotiating skills
• Customer focused and team spirited
• The ability to manage several projects at the same time by applying project management skills
• Process driven. Able to make recommendations for improvement to existing processes or construct new processes with input from cross functional groups

The role will need 2 days per week in their Reading office, the rest WFH (flexible on which days). The salary and benefits package are truly market-leading, and the scope for career progression is huge with this company.

If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.