Regulatory Affairs Manager (Part time, Home based)

  • Lynam Pharma
  • Aylesbury, UK
  • Oct 09, 2020

Job Description

Lyna m Pharma Limited, is a small pharmaceutical business based in Aylesbury, Buckinghamshire. As part of a new product development project, we are seeking an enthusiastic and motivated individual for a 6 month contract, part time 3 days a week. Parts of this role will be home based, with an expectation that the successful applicant will be working in our office in Aylesbury approximately 1 day a week (COVID 19 dependent). Salary is 50,000 a year on a pro rata basis.

Do you have experience in research development or design and development of medical devices? Do you have, or would like to gain experience in pharmaceutical wholesaling? If yes, then this role is for you. This is a part time contract role on a 6 Month contract, 3 days a week.

As the Regulatory Affairs Manager, you will be responsible for developing and implementing the regulatory strategies for product development and approval for a novel medical device as well as supporting the regulatory activities of our pharmaceutical wholesale division in conjunction with the responsible person.

Key roles and activities

  • Ownership of regulatory documents, submissions, and compliance issues.
  • Working with regulatory agencies
  • The successful development and implementation of regulatory strategies for new registration submissions including post-approval compliance for our novel medical device.
  • Work with development team through all stages to ensure the product is in line with regulatory strategy
  • Provide strategic guidance and regulatory leadership at project team meetings
  • Identifying regulatory risks associated with the execution of regulatory strategies as well as defining strategies to mitigate risks.
  • Responsible for coordinating the preparation of the regulatory submissions including responses to questions from the regulatory / health agencies.

Key skills

Demonstrate strong organisational skills

Strong interpersonal skills and the ability to deal effectively with a variety of personnel

High attention to detail and ability to work to timelines.

Qualifications required for this position

Minimum 3 years pharmaceutical/medical device industry experience (including 2 years of Regulatory Affairs experience).

Education: BA/BS/University degree required, Life/Health Sciences preferred.

Please note, as this job is home based a strong internet connection is required.

Contract length: 6 months

Part-time hours: 22.5 per week

Application deadline: 21/09/2020

Job Types: Part-time, Temporary, Contract

Salary: £50,000...... click apply for full job details