We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Regulis, part of Pharmalex UK is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Regulatory Affairs Project Manager
To manage medicines projects to achieve a professional and high-quality service to clients. To provide consultancy to clients on a variety of complex regulatory projects and support the Regulatory Affairs Manager to grow the business by building strong relationships with existing clients. To build positive working relationships with clients and regulatory agencies, including account management of clients.
- Establish and maintain excellent working relationships with client companies and their personnel.
- Advise clients on regulatory strategy and fit this to the client’s overall business objectives, as well their financial, resource and time constraints.
- Prepare, submit and gain approval of regulatory applications to Regulatory Agencies.
- Interpret and respond to regulatory questions to resolve issues.
- Assess scientific data and prepare scientific documents to support regulatory applications.
- Influence key players in the regulatory process, including Regulatory Agencies.
- Plan, manage and execute projects and monitor progress to meet defined objectives and timescales.
- Draft and review all types of regulatory documentation.
- Develop and maintain a thorough knowledge of European, EU national and US regulatory requirements.
- To identify and assess emerging regulatory intelligence and to share this information with other colleagues and clients in a timely manner.
- To support the Regulatory Affairs Manager with business development opportunities.
- To account manage clients, and build and maintain strong working relationships with client company personnel.
- To actively contribute to monthly team meeting discussions.
- Travel to client meetings in the UK and abroad as required by the business.
- Be flexible to respond to client demands (sometimes outside normal office hours).
- Maintain the Company’s philosophy and work ethos.
- Support the Regulatory Affairs Manager with the preparation of project proposals and cost estimates.
- Effectively delegate projects to team members, when required.
- Support the Regulatory Affairs Manager in the creation of a monthly report to the Managing Director.
- Mentor less experienced team members.
- Deputise for the Regulatory Affairs Manager when needed
- University degree in pharmacy or other natural sciences
- Proven experience in evaluation, preparation and compilation of quality documentations and/or experience in regulatory processes (registration procedures, renewals, variation procedures) with special emphasis on quality aspects
- Ability to implement tactical goals of customer or internal projects within daily work
- Structured, analytical, systematic and independent manner
- Capability of supervision, prioritization and processing of parallel projects and tasks
- High service orientation
- Ability to manage internal and external (client) relationships on operational as well as client’s team lead level
- Excellent team player
- Professional written and spoken communication skills with internal and external customers, colleagues and supervisors. Experienced user of the MS-Office package, Adobe Acrobat and database systems
- English language fluency, written and spoken
- 25 Days holiday plus BH
- The role can be based at any of our UK locations.
- An opportunity to work within an organisation with a positive work/life balance environment
- Continuous development opportunities through knowledge and experience as well as training
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receiving your CV and a covering letter, explaining how you meet or exceed the specifications for this position, including your salary expectations on-line.
To apply, please use the "apply now" button below
Agencies only by prior agreement for the specific job opportunity.