Regulatory Lead

Essential Pharma; Egham; On-site; GBP 80,000 - 100,000; Full time

Job summary

A growing pharmaceutical company in the UK is looking for a Regulatory Affairs Director to ensure compliance with regulatory requirements for established products. Responsibilities include developing regulatory strategies, leading interactions with regulatory agencies, and managing a regulatory team. Candidates should have an advanced life sciences degree and experience with lifecycle regulatory activities. The role offers a competitive salary and benefits including a pension plan and flexible work arrangements.

Benefits

Competitive salary

Flexible work arrangements

£150 towards home office

Healthcare

Pension contribution

Life Insurance

Enhanced family leave

25 days annual leave

Discretionary annual performance bonus

Qualifications

• In depth knowledge of European and ROW regulatory environment.
• Regulatory expertise in life cycle management including maintenance of drug licenses.
• Significant experience managing lifecycle regulatory activities for established products.

Responsibilities

• Develop and implement regulatory strategies for established products.
• Lead interactions with regulatory authorities.
• Collaborate with Commercial and Pharmacovigilance teams.

Skills

Excellent oral and written communication in English language

Proficient in Microsoft Word

Proficient in Microsoft Excel

Proficient in Microsoft PowerPoint

Ability to think strategically

Agile thinking

Problem-solving skills

Integrity and high ethical standards

Education

Advanced degree in life sciences

Job description

Job Description

Regulatory Affairs Director for Established Products ensures compliance with regional and global regulatory requirements for existing and newly acquired established products, develops and implements regulatory strategies, leads interactions with regulatory agencies and manages a regulatory team. Drives strategic planning based on European or UK regulatory guidelines for all Therapeutic Areas in the company. If you are keen to join a patient centric, high-growth company, then read on and apply today!

Job Requirements

Qualifications

• Advanced degree in life sciences
• In depth knowledge of European, and ROW regulatory environment
• Regulatory expertise of life cycle management including maintenance of drugs licenses in EU or UK

Experience

• Must have significant experience of managing lifecycle regulatory activities for established products including new therapeutic indication registration and safety variations impacting SmPC and Package Leaflet
• Prior hands‑on experience of marketing authorisation transfer and leading technology transfer in EU or UK
• Proven hands‑on experience with EU or UK regulatory procedures, especially MRP / DCP / CP and NP
• Previous demonstration of working effectively with Manufacturing, Science & Technology team (MSAT) is desirable
• Experienced in working in a matrix environment

Competencies

• Excellent oral and written communication in English language
• Proficient in Microsoft Word, Excel, PowerPoint
• Ability to think strategically within in fast paced environment
• Think strategically and critically evaluate risk to regulatory activities
• Strong agile thinker who can adapt to situations of high-speed change
• Problem solver who can work through complex issues
• Demonstrate a growth mindset and able to coach team members
• Must demonstrate integrity and high ethical standards
• Demonstrates a willingness to achieve goals together and respect the view of others
• Well versed in CMC and clinical variation classifications and submission requirements

Job Responsibilities

• Develop and implement regional and global regulatory strategies for established products
• Lead and manage interactions with regulatory authorities
• Collaborate with Commercial, Pharmacovigilance for clinical, safety variations and geographic expansion
• Accountable for compliance by adhering to internal processes and external regional regulatory requirements
• Define the strategy to address regulatory changes in global markets and share knowledge
• Lead and coach Regulatory Professionals: make feedback to develop team members, define clear objectives for the team in alignment with company goals, make responsible decisions to drive performance

Job Benefits

• 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
• £150 towards your home office
• 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