Senior Regulatory Affairs Associate – CMC & Strategy

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Senior Regulatory Affairs Associate – CMC & Strategy (Cambridge, UK)

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The Opportunity

Cycle Pharmaceuticals is looking for an enthusiastic and talented team player to join its growing Product Development Department as a Senior Regulatory Affairs Associate – CMC & Strategy.

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 have dual responsibilities which comprises pre- and post-approval CMC submissions authoring (line extensions/additional indications for existing products, with support from the line manager and external parties) and regulatory strategy for new development projects at Cycle.

You will be working across different therapeutic areas including metabolic, immunology and neurology. Internally you will interact with key business areas such as Product and Clinical Development, Supply Chain, Quality, Legal and Finance. Your external interactions will consist of product providers, suppliers and partners, as well as formal agencies responsible for licensing and approvals.

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. Coaching and mentoring to support continuous learning and professional development will be provided and tailored to individual needs.

Our Company

At Cycle, we believe that Every Single Patient Matters, this is at the heart of why we work, and we’d love for you to share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen.

We are a pioneering pharmaceutical company, reimagining how drugs and services can benefit patients with rare disease to make their lives easier and improve their quality of life. Cycle, as a company, works closely with patient groups and healthcare professionals to understand the unmet needs of patients and their carers. By collaborating with academic communities and using the latest cutting-edge pharmaceutical technologies, we translate innovations into medicinal products that patients and caregivers actually desire. We deliver the required medicine with the minimum impact on daily routines and, just as importantly, provide individualized support services to patients, families, carers and the healthcare professionals community.

Cycle has three core areas of pharmaceutical development and work across rare metabolic, immunological and neurological genetic conditions: improving drugs – optimizing an existing drug; repurposing drugs – creating a new indication for an existing drug; and generics – reinstating generic drugs, previously available in the market. These three areas of focus are underpinned by formulation technology – using new drug delivery technologies to improve the efficacy and effectiveness of drugs, allowing us to give patients greater freedom and choice.

Job Title: Senior Regulatory Affairs Associate – CMC & Strategy
Cycle Company: Cycle Pharmaceuticals Ltd
Position Summary: This is a full-time position within the Product Development department, working in our Cambridge office.

What you will be doing

  • Your key responsibilities will include:
  • Prepare CMC documentation (M1, M2 and M3) for eCTD and NeeS post-approval submissions for main markets such as US, Canada, EU, UK and International markets as required.
  • Co-ordinate the regulatory submission process and ensure regulatory documents are prepared in line with agreed strategic goals and timelines, and in compliance with applicable regulatory requirements.
  • Assess change controls, conduct gap analyses and review of stability protocols, batch records, and other technical documents.
  • Monitor and analyse available regulatory information for key regulatory websites (e.g. FDA, EMA, ICH etc.)
  • Provide and maintain MA documentation support by managing submission tracking spreadsheets and databases, and generation of compliance files.
  • Support line management in performing risk and issue management for regulatory strategy – identifying risks and inputting into identifying suitable mitigations, and contributing to resolution of issues, with support of external parties as needed.
  • Provide technical and strategic product development and regulatory advice on products currently under development in Cycle’s product pipeline.
  • Progress the regulatory strategy and make recommendations to ensure the success of the strategy, including identifying communication pathways with regulatory agencies.
  • Prepare and manage regulatory strategy activities during the development phase, including but not limited to, pre-IND/Type C meetings and associated documents, Orphan Drug Designation applications etc.
  • Attend regulatory advice meetings/teleconferences whenever required by global health authorities.
  • Prepare SOPs and Work Instructions as necessary.

You will also:

  • 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.
  • Act as a primary contact with third party consultancy companies for assigned projects, including maintaining budgets and contracts.
  • Proactively maintain knowledge of relevant regulatory environments and communicate the implications of regulatory intelligence findings to senior members of the team and other functions.
  • Support line management to develop and improve procedures and processes used by the Regulatory group and in the preparation and management of regulatory budgets.

What will enable you to thrive
The following skills and experience will be important in helping set you up to succeed and thrive in this role

  • A minimum of a B.Sc. in a Life Sciences subject (e.g. Biology, Biochemistry, Chemistry, Pharmacy etc.)
  • 2+ years’ CMC submissions authoring experience
  • Experience working in pharmaceutical product development for an SME biotech/small pharma or academic institution.
  • Good technical knowledge of medicinal products including formulation and/or analytical activities.
  • Understanding of regulatory procedures in region US and EU for MAAs, NDAs and knowledge of full lifecycle drug development.
  • A strong ability to quickly assimilate, interpret and summarise scientific information with limited external input.
  • Demonstrable aptitude for IT packages such as Word, Excel and PowerPoint.

If you had any of the following skills and experience it would be advantageous

  • Experience in regulatory affairs strategy.
  • Experience with non-US regulators, and experience with US-FDA
  • Understand of non-clinical/clinical development and different areas of regulatory affairs including labelling.

What makes this role special

  • Seek to have a profound impact on patients and their families.
  • Work across a range of different disease states.
  • Mentoring, coaching and training that will give you the opportunity for personal and professional development.
  • Help shape the culture and future of an emerging pharmaceutical company with a grand vision.
  • Work with a growing team of experienced professionals.
  • Learn from a strong leadership team with a proven history of success.

What can we offer to you
In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:

  • Competitive salary based on experience
  • A collaborative high performing work environment
  • 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

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.

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