Senior Regulatory Affairs Associate / Regulatory Affair Manager (CMC) (Cambridge, UK ) 

The Company:

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, immunological 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 utilize 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 individualized support services to patients, families, caregivers, and the healthcare professional community.

We are looking for a Senior Regulatory Affairs Associate / Regulatory Affair Manager (CMC) based in Cambridge, UK to fill fixed term contract. This is an exciting and unique opportunity to join Cycle at a very important period of growth.  We are looking for a self-starter, entrepreneurial and commercially minded individual who is not afraid of challenges and that is passionate about making a difference to patients’ lives.

Job Title

Senior Regulatory Affairs Associate / Regulatory Affair Manager (CMC)

Overview of the role

Featured as one of “The Sunday Times 10 Tech Track Ones to Watch 2020,” we are looking to recruit a person with a minimum of 5 years experience in CMC to become part of our Regulatory team

Responsibilities

  • Act as a key player in the execution of CMC regulatory strategies working on multiple cross functional projects.
  • 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 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.
  • Review quality documents including deviations, risk assessments and change controls providing CMC regulatory input.
  • 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.
  • Communicate the implications of the regulatory intelligence finding to senior members of the team and other functions.
  • Provide and maintain MA documentation support by managing submission tracking spreadsheets and databases, and monitoring compliance file generation.
  • Work with Cloud based document management system for key registered details.

Qualifications and Skills

Qualifications:

  • Science degree or equivalent qualified (minimum of a B.Sc. in a Life Sciences subject):g. chemical and physical sciences, pharmacy, biochemistry.

Skills and Experience:

  • A minimum of 4-5 years of regulatory experience ideally working on product registrations for US and/or EU market in a CMC role (MAs, NDAs, ANDAs).
  • Understanding of regulatory procedures in region US and/or 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.

Personal Attributes and Experience

  • 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.

Working Conditions & Environment

The role will be based in our new Cambridge office but some travel to attend meetings may be required. However, with the ongoing current COVID-19 situation, we will enable you to work flexibly from home for part of the week, and other travel will be limited until the wider situation stabilises.

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

Applications:

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 send us your CV and covering letter
Send an email to Careers@cyclepharma.com