Regulatory Manager

Role Overview

The Regulatory Manager will oversee regulatory processes pertaining to Marketing Authorisation Applications (MAAs), ensuring seamless preparation, submission, and management of regulatory documents and responses. The position requires close cooperation with internal departments, Contract Manufacturing Organisations (CMOs), external partners, and consultants to meet deadlines and comply with regulatory standards.

Key Responsibilities

• Lead and coordinate responses to deficiencies related to MAAs, ensuring precise, timely, and regulation-compliant submissions.
• Prepare, compile, and assess high-quality regulatory documents for accuracy, completeness, and adherence to regulatory frameworks.
• Monitor and manage timely replies to regulatory authorities' queries and information requests.
• Develop scientifically robust justifications and well-founded regulatory arguments to address authorities' concerns effectively.
• Gather and critically analyze scientific, technical, and clinical data to bolster submissions, responses, and regulatory strategy formulation.
• Review GMP-related documents from CMOs, verifying their conformity to regulatory standards.
• Maintain rigorous regulatory documentation protocols upholding global regulatory guidelines and internal processes.
• Offer regulatory assistance and direction to cross-functional teams such as Quality, R&D, Supply Chain, and Commercial.
• Collaborate closely with both internal and external stakeholders to align and implement regulatory strategies successfully.
• Ensure efficient communication with partners, CMOs, and consultants to obtain necessary data and documentation promptly.
• Track regulatory project schedules, monitor key milestones, and proactively engage stakeholders to meet deadlines.

Required Qualifications and Experience

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or related scientific area.
• Advanced qualifications in Regulatory Affairs or related disciplines are favorable.
• Minimum of six years' experience in Regulatory Affairs within the pharmaceutical sector.
• Proven track record handling regulatory documentation preparation, review, and submissions as well as deficiency management.
• Experience reviewing GMP-related documents from CMOs is beneficial.
• Prior exposure to UK and/or EU regulatory frameworks is preferred.

Skills and Competencies

• Thorough knowledge of pharmaceutical regulatory requirements and guidelines.
• Strong scientific and analytical capability to interpret complex data critically.
• Excellent written and verbal communication skills for clear regulatory correspondence.
• Ability to draft precise, scientifically sound regulatory justifications and responses.
• Attention to detail and dedication to quality and accuracy.
• Effective organizational and project management skills to balance multiple priorities.
• Adept at collaborating across teams and with external stakeholders.
• Proactive in identifying and addressing regulatory challenges.
• Strong interpersonal and teamwork aptitude.
• Proficiency in Microsoft Word and Excel.
• Capability to work independently while contributing efficiently within a team setting.