Regulatory Affairs Associate
- Recruiter
- Michael Page
- Location
- Cambridge
- Salary
- Competitive
- Posted
- 02 Jul 2022
- Closes
- 08 Jul 2022
- Sectors
- Engineering, Defence
- Contract Type
- Permanent
- Hours
- Full Time
As a Regulatory Affairs Associate / Senior Associate you will be responsible to provide technical and regulatory input to new development projects at Cycle and support the planning of ongoing product registrations at Cycle. You will be working across different therapeutic areas.
Client Details
Our sole aim is to deliver best-in-class drug treatments and support 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. Our approach is to utilize the latest cutting-edge pharmaceutical technologies to deliver the required medicine, with the minimum impact on daily routines.
Description
Key Duties and Responsibilities:
Provide technical and strategic product development and regulatory advice on products currently under development in product pipeline
Research and analyse scientific data from scientific publications and regulatory dossiers of approved products and provide insights and summary documents to internal key stakeholders as part of decision-making process
Prepare and review documents for regulatory submissions, in particular module 2 clinical and non-clinical summaries
Provide project management support to ensure regulatory documents are prepared in line with agreed strategic goals and timelines, and in compliance with applicable regulatory requirements
Prepare gap analyses and relevant sections of product development plans, and support the Head of Regulatory Affairs in defining regulatory strategies
Engage in regulatory authority meetings by preparing meeting requests and meeting package and attending teleconferences whenever required by global health authorities
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
Profile
Required Knowledge
A high scientific calibre with a life science focused BSc.
Higher degree (e.g., a life science focused MSc or PhD) would be preferrable
At least 2 years practical/technical experience in pharmaceutical product development, working within SME biotech/small pharma or in academic environment preferably in Regulatory Affairs in pre submission and post approval management of licenses.
A good understanding of the regulatory regulations in EU and USA
Required skills
Excellent written and oral communication.
A strong ability to quickly assimilate, interpret and summarise scientific information Ability to work in a proactive and autonomous manner, as well as being part of a team.
Good project management skills with a high level of attention to detail.
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.
Job Offer
Competitive Salary
Flexible working
Work across a range of different disease states;
Opportunity for professional development and training
Client Details
Our sole aim is to deliver best-in-class drug treatments and support 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. Our approach is to utilize the latest cutting-edge pharmaceutical technologies to deliver the required medicine, with the minimum impact on daily routines.
Description
Key Duties and Responsibilities:
Provide technical and strategic product development and regulatory advice on products currently under development in product pipeline
Research and analyse scientific data from scientific publications and regulatory dossiers of approved products and provide insights and summary documents to internal key stakeholders as part of decision-making process
Prepare and review documents for regulatory submissions, in particular module 2 clinical and non-clinical summaries
Provide project management support to ensure regulatory documents are prepared in line with agreed strategic goals and timelines, and in compliance with applicable regulatory requirements
Prepare gap analyses and relevant sections of product development plans, and support the Head of Regulatory Affairs in defining regulatory strategies
Engage in regulatory authority meetings by preparing meeting requests and meeting package and attending teleconferences whenever required by global health authorities
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
Profile
Required Knowledge
A high scientific calibre with a life science focused BSc.
Higher degree (e.g., a life science focused MSc or PhD) would be preferrable
At least 2 years practical/technical experience in pharmaceutical product development, working within SME biotech/small pharma or in academic environment preferably in Regulatory Affairs in pre submission and post approval management of licenses.
A good understanding of the regulatory regulations in EU and USA
Required skills
Excellent written and oral communication.
A strong ability to quickly assimilate, interpret and summarise scientific information Ability to work in a proactive and autonomous manner, as well as being part of a team.
Good project management skills with a high level of attention to detail.
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.
Job Offer
Competitive Salary
Flexible working
Work across a range of different disease states;
Opportunity for professional development and training