We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, PharmaLex 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.
This position can be based from anywhere in the UK or Ireland. It can be a home-based role, office-based or a hybrid home/office arrangement for the right candidate.
Director, Principal Consultant, Development Consulting and Scientific Affairs
This is a new position that has been created in our Development Consulting and Scientific Affairs department. The role will provide a wide range of flexible services for different clients on a variety of product types and therapeutic areas. You will also cover a broad range of strategic and operational clinical and non-clinical regulatory affairs activities, including both pre-and post-authorisation.
- Regulatory strategy and contributing to development programmes
- Regulatory intelligence
- Assessment of scientific data
- Strategic input into and preparation and management of regulatory submissions and procedures (e.g. for national or centralised scientific advice procedures, marketing authorisation applications, orphan designations, post-authorisation procedures, PIPs, waivers and/or deferrals). Includes advising clients of best strategy and navigating clients through the processes in addition to hands-on activities required to prepare and submit documentation
- Representation of clients with regulatory authorities including acting as the primary contact point and taking a leading role in teleconferences and face-to- face meetings with regulatory agencies
- Writing/input into eCTD Modules, as applicable
- Licensing and ‘due diligence’ activities
- Participation in business development activities for the UK and international group.
- Educated to at least degree level in pharmacy, medicine, chemistry or a life science subject with a higher degree being preferable
- At least eight years in ‘hands on’ regulatory affairs roles and experienced in a broad range of regulatory submission types with a thorough grasp of EU regulatory requirements
- Autonomous, concentrated and high-quality work
- Ability to work in a team
- Sense of responsibility
- Excellent written and verbal communication skills, including effective and professional client- facing interactions
- High attention to detail
- Commercial outlook and strong management of clients’ budgets.
- 25 days holiday plus bank holidays (increasing to 27 days after qualifying service)
- 8% employer pension contribution
- 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 receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Ms / Mr Pietropaolo
Manager Human Resources UK
Agencies only by prior agreement for the specific job opportunity.