Job Title: Regulatory Affairs – Global CMC Specialist
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 Affairs department.
Key Duties and Responsibilities:
- Primary point of contact for chemistry, manufacturing and control (CMC) regulatory documents.
- Liaise with internal stakeholders as well as Contract Manufacturing Organisations to assemble and review key quality documents to ensure regulatory compliance.
- Preparation of high-quality CMC regulatory documents for small molecule products to support global regulatory submissions.
- Collaborate with Product Leads to develop Target Product Profile and Regulatory Strategy.
- Act as the Information and Regulatory Change Control Owner for CMC activities and oversee delivery for the team.
- Work to agreed deadlines, with ability to respond readily to changing events and priorities.
- Opportunity to grow within the role and take leadership in CMC strategy with a future potential of line management.
- Create and/maintain regulatory systems as required (submission tracking, gap analysis etc.).
Qualifications & Skills:
- Degree in Pharmacy, Chemistry or related discipline, or with extensive experience of working within CMC in Regulatory Affairs (3 years min).
- An accomplished working knowledge of the formulation and / or analytical aspects of pharmaceutical R&D (minimum 2 years).
- Excellent written and oral communication.
- Ability to work in a proactive and autonomous manner, as well as being part of a team with the ability to establish strong relationships and liaise effectively with Contract Manufacturing Organisations worldwide.
- Good problem solving and critical thinking in complex, multidisciplinary situations (ideally this would include some programming experience (VBA etc).
- Demonstrate a ‘can do’ attitude to assume responsibilities beyond own space when the circumstances demand.
- Ability to focus, work with attention to detail and retain critical information.
- Effective organizational / project management skills.
- Ability to express a scientific opinion clearly and concisely and to support the defense of regulatory decisions.
- Be proficient in the use of IT packages such as Word, Excel and Document Management systems (specifically Veeva).
- CMC Regulatory Affairs experience; planning, authoring, reviewing and project management of regulatory submissions.
- Global experience (including EU, US, CA & UK), in the following types of CMC submissions:
- MAAs/NDAs and/or Lifecycle Management for medicines and managing the related responses to questions
- Briefing documents for Scientific Advice Meetings (Pre-IND, Type C Meetings)
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 success.
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, typically 2 days a week, and office-based working, and the flexibility to manage start and finish times around our core working hours of 10 am 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.