Job Title: Regulatory Affairs Associate
Cycle Company: Cycle Pharmaceuticals Ltd
Location: Broers Building, 21 JJ Thompson Ave, Cambridge, CB3 0FA
Position Summary: This full-time position sits within the Regulatory department.
Key Duties and Responsibilities:
- 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 non-clinical 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 Regulatory Affairs 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
Qualifications & Skills:
- A high scientific calibre with a life science focused BSc.
- 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 preferably in Regulatory Affairs in pre submission and post approval management of licenses.
- A good understanding of the regulatory regulations in EU and USA
- Excellent written and oral communication.
- A strong ability to quickly assimilate, interpret and summarise scientific information 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.
What makes this role special:
- Seek to have a profound impact on patients and their families;
- Work across a range of different disease states;
- Opportunity for professional development and training;
- Help shape the culture and future of an emerging pharmaceutical company with a grand vision;
- Collaborate with a growing team of experienced professionals;
- Learn from a strong leadership team a with a proven history of
Working Conditions & Environment
The role will be based in our new Cambridge office but some travel to attend meetings may be required. We have an agile working policy which allows for a mixture of home and office-based working, and the flexibility to manage start and finish times around our core working hours of 10am to 4 pm.
Employee Benefits at Cycle Pharmaceuticals
In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will be part of the Cycle ‘family’ and enjoy all the benefits that brings:
- Competitive salary based on experience
- Performance based bonus
- Opportunity to join a fast growing and ambitious business
- Company pension scheme
- 100% employer paid membership for Private Health Insurance
- Life and Critical Illness Insurance
- Corporate Gym membership
- Regular team building events and an agile working environment
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.
Please submit applications to email@example.com