Head of Research & Development: Oral Solid & Liquid Dosage Forms

On offer is the opportunity to develop in a young and rapidly growing pharmaceutical company, Key Pharmaceuticals. The organisation operates as a virtual generics company which holds its own marketing authorisations (primarily oral dosage forms) within the United Kingdom/ EU and United Arab Emirates.

Key Pharmaceuticals is part of the Bestway Healthcare Group, a vertically integrated business.

About the Role

We are seeking a visionary and experienced Head of R&D to lead formulation development and regulatory strategy for oral solid and liquid generic dosage forms. This role is pivotal in driving innovation, ensuring regulatory compliance, and accelerating product development for highly regulated markets such as the UK and EU.

Key Responsibilities:

• Strategic Leadership

• Define and execute the R&D roadmap aligned with business goals for UK/EU generic markets.
• Lead cross-functional teams in formulation, analytical development, and regulatory affairs.

• Formulation Development

• Oversee development of oral solid (tablets, capsules) and liquid dosage forms (solutions, suspensions).
• Ensure robust, scalable, and cost-effective formulations that meet bioequivalence and stability criteria.

• Regulatory Compliance

• Ensure all development activities comply with MHRA, EMA, and ICH guidelines.
• Lead dossier preparation (CTD format) for EU submissions including Module 3 and bioequivalence documentation.

• Project Management

• Manage timelines, budgets, and resources across multiple development projects.
• Collaborate with manufacturing, QA/QC, and supply chain teams to ensure seamless tech transfer.

• Innovation & Technology

• Evaluate and implement new technologies in formulation and analytical sciences.
• Drive continuous improvement and lifecycle management of existing products.

• Team Development

• Build and mentor a high-performing R&D team.
• Foster a culture of scientific excellence, compliance, and innovation.

Qualifications & Experience

• PhD/MPharm/MSc in Pharmaceutics or related field.
• Minimum 1215 years of experience in generic pharmaceutical R&D.
• Proven track record in developing oral solid and liquid dosage forms for UK/EU markets.
• Strong knowledge of regulatory frameworks (MHRA, EMA, ICH).
• Experience in bioequivalence studies and regulatory submissions.
• Excellent leadership, communication, and project management skills.
• Familiarity with QbD, PAT, and risk-based development approaches.
• Exposure to EU GMP audits and regulatory inspections.
• Experience with technology transfer to GMP approved manufacturing sites.