The Regulatory Manager is responsible for managing and supporting all regulatory activities across UK, Switzerland and Rest of World (ROW) markets, ensuring that product licences are maintained in compliance with applicable local and regional regulatory requirements. The role contributes to lifecycle management, regulatory strategy execution, and supports business continuity across both marketed and non-marketed portfolios, with occasional involvement in EU procedures. If you are keen to join a patient centric, high-growth company, then read on and apply today!

Responsibilities

Preparation, review and submission of regulatory applications including variations, renewals, MAAs and MATs across UK, Switzerland and ROW

• Support regulatory approval and maintenance of products in global locations in conjunction with local partners or licence holders.
• Prepare and/or review product information text.
• Work closely with CMO regarding implementation of product artwork.
• Review product regulatory compliance periodically.
• File regulatory documentation internally, maintain comprehensive product files.
• Advise on Change Controls for Regulatory function.
• Initiate Change Controls for regulatory changes.
• Communicate regulatory changes to contract manufacturing organisations (CMOs) and other interested parties both prior to and following update of the Marketing Authorisation dossier.
• Collaborate with Pharmacovigilance and Medical Affairs departments regarding safety/core datasheet updates initiated by health authorities or Safety Data Exchange partners.
• Participate in project teams concerning technical transfers or technical changes to products
• Review potential acquisition proposals and contribute to due diligence
• Participate in the integration team for selected acquired products.
• Ensure integration of the acquired product regulatory files into the internal filing system.
• Assist where required with responses to medical information enquiries and product complaints.

Requirements

Qualifications

• Degree in life sciences

Experience

• Regulatory Affairs (Pharmaceutical)
• UK/European/ROW

Core Competencies

• Strong Agile thinker who can adapt to situations of high-speed change
• Problem solver who can work through complex issues
• Candidate must demonstrate a Growth mindset and willingness to learn
• Must demonstrate integrity and high ethical standards
• Previous demonstration of working effectively as part of team with strong collaboration
• Demonstrates a willingness to achieve goals together and respect the view of others
• Results orientated and accountable for actions

Benefits

What We Offer

• Competitive salary
• We understand that productivity requires balance, so we offer office-based contracts and allow flexibility on locations of work when required and appropriate. This can be different for each department so please have that conversation at interview
• Healthcare
• Pension – you contribute 5% and we offer 5%.
• Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
• Enhanced family leave
• Enhanced sick pay
• 25 days annual leave
• Discretionary annual performance bonus

What To Expect

• At Essential Pharma, every colleague matters: we want every member of the team to thrive and grow during their time with us
• Right from the interview stage, we encourage candidates to ask us questions, voice opinions and be curious
• This is a dynamic, fast-paced working environment. We expect individuals to be responsible and accountable, while understanding the importance of collaborating with colleagues to fuel success
• We pride ourselves on our inclusive culture, based on the belief that everyone brings unique strengths and perspectives
• We have an unwavering dedication to employee growth and development