Head of Regulatory 12 Months FTC (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 Head of Global Regulatory Affairs based in Cambridge, UK to fill a fixed term maternity cover 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:

Head of Global Regulatory Affairs

Overview of the role:

Featured as one of “The Sunday Times 10 Tech Track Ones to Watch 2020,” we are looking to recruit a Head of Global Regulatory Affairs into our expanding UK team.

Working with Cycle’s COO and the wider leadership of the Operations team, you will provide leadership and management to the regulatory, clinical, labelling and PV teams, and take responsibility for the registration and maintenance of licences for pharmaceutical products, pharmacovigilance activities and clinical activities of Cycle Pharmaceuticals products globally. You will provide regulatory, clinical, labelling and PV advice to the wider Cycle team in respect of current assets and attend internal and external stakeholders meetings as part of the leadership team. The role will be responsible for the development of the team as a group and for the individuals through mentoring, coaching and acting as a role model.

Responsibilities
Provide leadership and technical support to ensure the development of a team that delivers:
• Up-to-date regulatory expertise on marketing authorisations requirements and procedures to develop faster to market product development and approval strategies with optimal labelling that support the commercial goals.
• Provides a key interface for Cycle Pharmaceuticals with global regulatory agencies and external partners.
• Define strategies for life cycle management, maintenance and compliance of existing marketed assets.
• Maintain a pharmacovigilance and labelling systems that support existing and new assets.
Contributes to the strategic and commercial success of Cycle Pharmaceuticals as a whole by:
• Ensuring regulatory strategy plans are in place for all assets and that they are optimized in respect of regulatory approvals, maintenance and pharmacovigilance.
• Ensure regulatory strategies for registration and life cycle maintenance of product licences are delivered on-time and in accordance to agreed budget.
• Manage CRO (clinical, regulatory, pharmacovigilance) and partner relationships where regulatory/clinical interaction is required.
• Provide leadership and mentoring to Clinical Manager and act as a project director for all clinical projects at Cycle in support of CRO activities and contribute to the development and QC review of study protocols, Consent Forms, CRF and other documents essential for the execution of clinical studies.

Takes ownership of individual and team objectives, and is accountable in achieving results:
• Facilitate teamwork, undertake mentoring and provide guidance to team members as needed.
• Promote the work of the team as a valued resource within the company.
• Act as role model for leadership attributes, in particular demonstrating vision and strategic focus, being inspirational, have awareness of the bigger picture, maintain flexibility and create an environment in which people are encouraged and able to model these behaviours.
• Responsible for the Regulatory, Pharmacovigilance and Clinical budget planning, approval and maintenance.
• Responsible for the recruitment of new team members into the regulatory department.
Qualifications and Skills

Qualifications:
• Science degree or equivalent qualified: e.g. chemical and physical sciences, pharmacy, biochemistry, medical chemistry, biomedical science; or HND with extensive regulatory/clinical experience working in drug development role.
Skills and Experience:
• Track record of overseeing a substantial number and quality of drug submissions, approvals and maintenance activities working with or from within health authorities such as EMA, FDA, HC, TGA and others.
• Ability to build relationships and inspire confidence and respect at all levels, excellent team player.
• Outstanding communication skills, ability to build rapport and demonstrate strong influencing and negotiation skills, excellent listening ability, receptive to feedback and demonstrates flexibility, curiosity and an ability to learn.
• Demonstrated negotiation skills in interactions with Health Authorities and/or internal/external stakeholders
• Experienced in budget management
• Able to work under pressure, deliver to tight deadline and capable of adapting to a fast pace ever changing landscape.
• Demonstrated project management skills for regulatory, pharmacovigilance and clinical projects.
• Strong ethical standards and a high level of personal integrity.

Personal Attributes and Experience
• The role will have both operational and strategic deliverables and the successful candidate will exert influence on the business so must have the ability to adapt and work across both these levels.
• Have good judgement and an ability to self-reflect to ensure that advice provided is not just correct, but practical, commercial and pragmatic in order to and suit the fast-paced nature of the business.
• Have an analytical and problem-solving approach to advice and guidance.
• A desire to learn and grow with a rapidly expanding business; thrives in fast-paced environment.
• Flexible, collaborative colleague; sense of humor a plus; Outstanding interpersonal and communication skills to establish and maintain excellent relationships with all levels of employees and external business associates.
• Impeccable ethics and integrity.

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: please send your CV and a cover letter to careers@cyclepharma.com

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