Senior Regulatory Affairs Manager

Pro4orm People Ltd have partnered with a global pharmaceutical company in the search of a Senior Regulatory Affairs Manager. We are looking to speak to people who have an excellent understanding and experience of European Regulatory requirements. This role is perfect for someone who is highly motivated, detail orientated and has a broad understanding of the requirements to place products on the market within the EU. This is a full time permanent position, based in Berkshire three days a week.

Key Responsibilities:

• This role will provide strategic regulatory and scientific support on non‐clinical and clinical development plans with an objective of getting fast access of innovative medicines to patients in the most efficient way.
• Provide regulatory input into development programs, registration documentation based on relevant regulatory guidance and critical assessment of data available for generic and speciality products.
• Identify the various guidelines relevant to product development and registration in the European region.
• Identify and analyse relevant guidance and provide input and make recommendations to team and/or key stakeholders.
• Critically evaluate data and scientific rationale to identify gaps and pre‐empt deficiencies prior to critical document closure in preparation of submission documentation.
• The role will actively be involved in due diligence of the dossier covering modules 1 to 5 and will be responsible to assess adequacy of these sections and any responses to questions during review.
• The role will work collaboratively with internal stakeholders and external stakeholders to finalize sections of MAA.

Requirements:

• An excellent understanding of European regulatory requirements to set up regulatory strategies in support of development programs for specialty products with focus on EU and other highly regulated territories.
• The following skills are essential for the role: Influencing, problem solving, time and project management, flexibility/adaptability, independence, team working, customer focus and effective inter‐cultural communication skills.
• Degree or higher degree in pharmacy, life sciences or equivalent.
• Experience with Regulatory Affairs and Microsoft Office software and databases (e.g. eCTD publishing and validation, CESP, MHRA portal, Eudralink, Excel etc.)

Pro4orm People Ltd is acting as an Employment Agency in relation to this vacancy. Pro4orm People Ltd is an Equal Opportunities Employer. Due to a high volume of applications we will only be able to contact successful applicants within 5 working days. We may, however, contact you regarding other potential roles of interest. By applying for this position you will be agreeing to our Terms and Conditions, and Privacy Policy which can be found on our website www.pro4ormpeople.com.

At Pro4orm People Ltd we are committed to fostering an inclusive and diverse workplace. We welcome applications from all qualified candidates regardless of race, gender, sexual orientation, religion, disability, or background.