Research, Development & Manufacturing Compliance Executive

Job Summary:

Research, Development & Manufacturing Compliance Executive - 12 Month FT Contract Role - Skills: PHd required
Requirements:

Title: Research, Development & Manufacturing Compliance Executive

Location: Middlesex

Job Accountabilities:

To visit all of Client's development sites within UK, Europe and Asia.
Communicating between Client and development sites
Establishes product design and performance objectives in consultation with other business functions
Liaise with production departments to investigate and resolve manufacturing problems
Develops research methodology, implements and reports upon research investigations undertaken
Plans work schedules, assigns tasks and delegates responsibilities to the research and development team
Monitors the standards of scientific and technical research undertaken by the research team
Ensuring the manufacturing of products are in line with the Companies expectations.
Negotiating with development sites in order to obtain the best possible deal.
Assessment of R and D and manufacturing facilities for capability and expertise for the development and manufacture of Auden's products.
Ensuring that the company's products comply with the regulations of the MHRA.
Provides regulatory information, guidance and support to the R&D, Commercial, Clinical and Quality functions with respect to the development of company products.
Responsible for the timely management, preparation, submission and follow up of regulatory submissions to Competent Authorities, in whose territories Client wish to operate.
Timely management, preparation, submission and follow up of licence variations and renewal approvals.
Writing clear, accessible product labels and patient information leaflets.
Specifying storage, labelling and packaging requirements.
Maintaining quality systems.
Ensures regulatory procedures and systems are implemented in order to comply with regulatory requirements and agreed quality standards.
Undertaking and managing regulatory inspections.

Job Knowledge, Skills and Experience:

Phd required
3 years experience
Science degree in either Chemistry, Microbiology or Pharmacist
A very good understanding of CTD module 1-5 especially module 3
Excellent communication skills
Excellent negotiation skills
Well organised and efficient
Good attention to detail
Ability to work to tight deadlines without errors
Multi lingual, preferred but not essential

Working Relationships

Day to day accountability to the NPD & Scientific Affairs Manager.
With overall accountability to the Managing Director.

NOTE: I am a senior recruiter within the industry across a number of job divisions for the pharmaceutical, biotech and CRO sectors. For a confidential and professional chat about your requirements/ career advice and the chance to register for free and receive weekly job updates, please call Alex on or email