Regulatory Affairs Specialist

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

Pension