Regulatory Affairs Specialist

Leicester, Meridian Business Park
Up to £33,000 per annum + 28 days holiday (Inc BH), pension and childcare voucher scheme
14 Feb 2018
14 Mar 2018
Contract Type
Full Time

Are you looking to join an award-winning pharmaceutical company? Morningside Healthcare Limited are excited to announce that we are currently looking to recruit a Regulatory Affairs Specialist to join our team in our new modern offices.

Duties and Responsibilities (including but not limited to):

  • Experience in Formulation Regulatory, specifically in the EU applications MRP/DCP
  • Quality review in CTD / eCTD format as per EU guidelines
  • Compilation of dossiers for EU timely submission
  • Close interaction with query response and coordination
  • Formulating regulatory strategy for filing various products in the EU
  • Compliance from regulatory point of view for audits and response.
  • Strategic planning and execution of the International Regulatory Audits (MHRA and other EU agencies)
  • Experience in Quality Systems and implementation
  • Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning
  • Implement QA systems and generate SOPs
  • Close interaction with contract manufacturers both in and outside the EU
  • Familiarity with readability testing would be helpful.

Background requirements:

  • Ability to work both independently and within a team structure;
  • Proven ability to lead, influence and motivate colleagues and external partners;
  • Good Knowledge of guidelines from EMEA.
  • Good Knowledge on tech transfer
  • Strong planning, presentation and interpersonal skills;
  • Strong work ethic, self-motivation, dedication, results orientation;
  • Significant working knowledge of the pharmaceutical product development process (e.g., regulatory requirements, GMP, clinical strategies, drug delivery etc.);
  • Understanding of the role of drug delivery in the pharmaceutical marketplace, in both scientific and business context (e.g., market exclusivity requirements, role of IP in life cycle management) is a plus.
  • Possession of first rate written and verbal communication skills.
  • Demonstrate good working knowledge of IT systems.
  • Ability to work to strict deadlines under pressure.
  • Possession of first rate written and verbal communication skills.
  • Ability to work to strict deadlines under pressure.
  • Extensive Relevant Regulatory Affairs experience
  • A strong technical background educated to degree level (or equivalent) in one of the life sciences.



On offer will be excellent on-going training and development as well as a market leading salary.

Benefits include;

28 days holiday (including public holidays)

Training and development

Staff discount

Childcare voucher scheme


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