Cycle Pharmaceuticals is looking to hire an enthusiastic regulatory professional to join and support the fast growth of Cycle’s Regulatory department based in its Cambridge office, UK to work as Regulatory Affairs Associate/Senior Associate (depending on experience). The successful candidate will be a team player and self‑starter eager to learn and able to multitask across multiple projects. As a Regulatory Affairs Associate/Senior Associate you will be responsible to provide technical and regulatory input to new development projects at Cycle and support the planning of ongoing product registrations at Cycle. You will be working across different therapeutic areas including metabolic and neurology. The Cambridge team is relatively small but highly dynamic, and the work environment is representative of an expanding company, hence requiring an adaptive and pragmatic mindset. Coaching and mentoring to support continuous learning and professional development will be provided and tailored to individual needs. This is fantastic opportunity for a dynamic and competent scientist, wanting to contribute to a growing business and a rapidly expanding team and wanting to enter or establish themselves in the regulatory space.
- Provide technical (non-clinical and clinical) and strategic product development and regulatory advice on products currently under development in Cycle’s product pipeline
- Research and analyse scientific data from scientific publications and regulatory dossiers of approved products and provide insights and summary documents to internal key stakeholders as part of decision-making process
- Prepare and review documents for regulatory submissions, in particular module 2 clinical and nonclinical summaries
- Provide project management support to ensure regulatory documents are prepared in line with agreed strategic goals and timelines and in compliance with applicable regulatory requirements
- Prepare gap analyses and relevant sections of product development plans, and support the Head of RA in defining regulatory strategies for Cycle’s products
- Engage in regulatory authority meetings (e.g. pre-IND meeting, scientific advice) by preparing meeting requests and meeting package and attending teleconferences whenever required by global health authorities
- Attend team meetings and engage with internal and external stakeholders providing regulatory support to the product development team
- Maintain knowledge of relevant guidance (in particular US-FDA focused) and provide advice on key requirements for development activities
Required technical skills
- A high scientific calibre with a life science focused BSc (e.g. Biology, Biochemistry, Pharmacy, Pharmacology, Toxicology etc.) as a minimum. Higher degree (e.g. a life science focused MSc or PhD) would be preferrable
- At least 2 years practical/technical experience in pharmaceutical product development, working within SME biotech/small pharma or in academic environment
- Any experience with animal work would be advantageous but not a prerequisite
- A strong ability to quickly assimilate, interpret and summarise scientific information
- General awareness of regulatory affairs is sufficient but having a more detailed insight into the regulatory environment for medicinal products would be an advantage
Required soft skills
- Excellent written and oral communication.
- Ability to work in a proactive and autonomous manner, as well as being part of a team.
- Good project management skills with a high level of attention to detail.
- Ability to create strong working relationships across the organisation and with external partners.
- Self-motivated, enthusiastic and hard-working.
- Strong analytical, organisational and problem-solving skills.
- Competitive salary based on experience
- Performance based bonus scheme
- Development and growth opportunities
- 25 days holiday plus bank holidays
- Gym membership
- Childcare voucher scheme
- Income protection & critical illness cover
- Life insurance
- Health insurance (BUPA)
- Contributory pension plan
Job type Full-time
Location Cambridge, United Kingdom, however, with the current COVID-19 situation, we may require you to work from home for all or part of the week.
Closing date for applications Rolling base. Please note this job was posted on 31 March 2021
Salary Depending on experience
Applicants must be eligible to work in the UK.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
Please send your application including cover letter and CV by e-mail to firstname.lastname@example.org.
Cycle Pharmaceuticals embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.