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 Senior Regulatory Affairs Associate. The ideal candidate will be a team player and self‑starter eager to learn and able to multitask across multiple projects. As a Senior Regulatory Affairs Associate you will be responsible for managing the day-to-day activities and 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. Reporting directly to the Head of Regulatory Affairs, This is a fantastic opportunity for a regulatory professional to boost their career in a rapidly expanding Regulatory team.
- Act as a key player in the execution of CMC regulatory strategies working on multiple cross functional projects with direct supervision from Head of RA.
- Responsible for the preparation of Module 3 sections of regulatory submissions across different phases of product development (from clinical to lifecycle) including writing of dossier components and formatting of documents per style guideCreate and maintain submission timelines and tables of contents, schedule meetings, drafting meeting agendas and minutes, managing document reviews and other tasks as requested.
- Provide varying levels of regulatory support to the development activities at Cycle, including attendance of product meeting with internal and external stakeholders (e.g. contract manufacturers, consultants).
- Review technical documents from regulatory standpoint including development reports, analytical methods and manufacturing documents.
- Prepare pre-IND and scientific advice documents for ongoing discussions with Health Authorities such as FDA and EMA.
- Monitor the current regulatory environment for changes (and opportunities) that may impact future regulations, guidance, policy, and legislation.
Required technical skills:
- A minimum of a B.Sc. in a Life Sciences subject (Pharmacy, Chemistry, Biology or related discipline).
- A minimum of 3-4 years of regulatory experience ideally working on product registrations for US and/or EU market (MAs, NDAs, ANDAs).
- Understanding of regulatory procedures in region US and EU for MAs, NDAs and comprehensive knowledge of full lifecycle drug development
- Good technical knowledge of medicinal products including formulation and/or analytical activities is required. Prior experience working in product development/manufacturing focusing on formulation and/or analytical activities would be a plus.
- Demonstrated project management skills.
- Demonstrable aptitude for IT packages such as Word, Excel, Access & PowerPoint.
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.
- 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 27 January 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.