Senior Regulatory Affairs Associate
- Experience Level
- Experienced (non-manager)
This is a fantastic opportunity for a regulatory professional to boost their career in a rapidly expanding Regulatory team.
Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering best-in-class drug treatments and services to the under-served rare disease patient community.
We focus on rare metabolic and neurological genetic conditions. Our patients typically require life-long treatment with life-saving medicine. Frequent and forever drug treatment can significantly impact the quality-of-life of patients. It can also impact the lives of their families and other caregivers. Cycle's approach is to utilise the latest cutting-edge pharmaceutical technologies to deliver the required medicine, with the minimum impact on daily routines. Just as importantly, Cycle is committed to provide individualised/ support services to patients, families, caregivers and the healthcare professional community.
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.
As a Senior Regulatory Affairs Associate you will be responsible to manage the day-to-day activities and the planning of ongoing product registrations.. You will be working across different therapeutic areas including metabolic and neurology. 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 guide.
- Create 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, 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.
Senior Regulatory Affairs Associate
- A minimum of a B.Sc. in a Life Sciences subject.
- 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.
- 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 holidays package plus bank holidays
- Gym Membership
- Childcare voucher scheme
- Income Protection
- Life Insurance
- Health insurance (BUPA)
- Critical Illness
- Contributory Pension Plan