We are growing, grow with us!
An exciting opportunity has arisen to join our development consulting, regulatory and scientific affairs team. Based in the UK at any of our affiliated offices (Buckinghamshire, Hertfordshire or Cornwall) or at our office in Ireland (near Dublin) the role provides a wide range of flexible services for different clients on a variety of product types and therapeutic areas. Whilst the role may cover a broad range of strategic and operational activities, including both pre-and post-authorisation, the focus is on pre-authorisation strategic consulting in respect of our clients’ development programmes from a non-clinical and clinical perspective. Projects may involve both small molecules and biological products.
Associate Director / Director Regulatory Affairs - Development Consulting
Although based in our UK/Ireland regional organisation, this position will support the projects undertaken by PharmaLex across our international offices throughout Europe, the US and beyond. Our client base is also truly international and diverse, ranging from biotech companies through to medium-sized and large pharma.
- Regulatory strategy and contributing to development programmes.
- Regulatory intelligence.
- Assessment of scientific data and technical writing, including overviews and summaries.
- Preparation and management of EU pre-authorisation procedures for example, Orphan Drug Designation applications, Scientific Advice/Protocol Assistance, Paediatric Investigation Plans, PRIME applications. Includes advising clients of best strategy and navigating clients through the processes in addition to hands-on activities required to prepare and submit documentation.
- Input into the strategic development and preparation of regulatory submissions for clinical trial authorisation applications and marketing authorisation applications.
- Representation of clients with regulatory authorities including acting as the primary contact point and taking a leading role in interactions with regulatory agencies.
- Licensing and ‘due diligence’.
- Supporting business development.
The ideal candidate should be educated to at least degree level in pharmacy, medicine, chemistry or a life science subject with a higher degree being preferable. Although a background in non-clinical and/or clinical activities is expected, exposure to and interface with CMC activities would be an advantage. Likewise, although the role may involve both small molecules and biologics a strong background in biological product development would also be an advantage. The following experience and attributes are also expected:
- At least eight years in ‘hands on’ regulatory affairs roles. Experience in pre-authorisation activities is essential; post-authorisation experience is also desirable.
- Experienced in a broad range of regulatory submission types with a thorough grasp of EU regulatory requirements and knowledge how to maximise access to the regulatory-based incentives that are available to companies developing medicines for Europe.
- Ability to work in a team.
- Sense of responsibility.
- Excellent written and verbal communication skills, including effective and professional client-facing interactions.
- Attention to detail.
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.
Agencies only by prior agreement for the specific job opportunity.