Senior Regulatory Affairs Executive, Lifecycle Management & Post-Marketing Compliance

Competitive Salary & Company Benefits. Ideally located close to Petersfield or Leicestershire. Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day).

Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.

The Role: The Senior Regulatory Affairs Executive, Lifecycle Management & Post-Marketing Compliance, is responsible for leading and executing complex post-approval regulatory activities for the company's marketed products. This team member will manage various types of variations, renewals, and post-marketing compliance submissions across multiple global regions. The role demands an experienced regulatory professional capable of acting as a subject matter expert, mentoring junior staff, and effectively collaborating with internal teams, especially Pharmacovigilance, to ensure continuous market availability and regulatory compliance.

Key Responsibilities

• Variation Management: Lead the preparation, compilation, and submission of all types of post-approval variations (e.g., quality, safety, administrative changes) to relevant global regulatory authorities.
• Renewal Management: Manage the timely preparation and submission of product renewals, ensuring all required documentation and data are submitted in accordance with regional regulations.
• Safety Update Submissions: Coordinate and prepare regulatory submissions for safety updates, including core data sheet updates, aggregate report summaries, and specific safety variations, in close collaboration with Pharmacovigilance.
• Response Management: Prepare comprehensive and timely responses to regulatory authority questions arising from post-approval submissions.
• Out-Licensing Support: Provide regulatory support for out-licensing activities, including the transition of regulatory responsibilities and documentation.
• Regulatory Intelligence: Monitor and interpret new and evolving post-marketing regulations, guidelines, and health authority communications. Assess their impact on existing products and recommend appropriate actions.
• Policy & Procedures: Contribute to the development and maintenance of internal regulatory policies and procedures related to post-marketing compliance and lifecycle management.

Collaboration & Communication

• Pharmacovigilance Liaison: Serve as a key regulatory contact for the Pharmacovigilance team, ensuring seamless communication and coordination for all safety-related regulatory activities.
• Cross-Functional Collaboration: Collaborate effectively with Quality Assurance, Supply Chain, Commercial teams and external partners to gather information for variations and renewals and to ensure regulatory requirements are met for ongoing market supply.
• External Interactions: Support the manager in interactions with regulatory authorities on post-approval matters, including discussions related to variations, renewals, and compliance issues.
• Mentorship: Mentor and provide guidance to junior regulatory team members, assisting in their development and understanding of lifecycle management processes.
• Tracking & Reporting: Maintain accurate and up-to-date tracking of all post-approval submissions, approvals, and commitments for assigned products. Provide regular status updates to the manager and relevant functional teams.
• Document Management: Manage the accurate and compliant translation of post-approval regulatory documents, coordinating with external vendors as needed.

Compliance & Quality Assurance

• Regulatory Compliance: Ensure all post-approval regulatory activities and submissions comply with relevant global regulations, ICH guidelines, and company standard operating procedures (SOPs).
• Quality Control: Conduct thorough quality control checks of post-approval regulatory documents and submissions prior to dispatch to regulatory authorities.
• Audit Readiness: Support internal and external audits/inspections by ensuring regulatory documentation for marketed products is complete, accurate, and readily accessible.
• Documentation: Maintain well-organised and audit-ready regulatory files and databases for lifecycle management activities.

The Person

Qualifications

• Education: Required: Bachelor's degree in a scientific discipline (e.g., Pharmacy, Biology, Chemistry, Medicine) or related field. Preferred: Advanced degree in a relevant scientific or regulatory field.
• Experience: Minimum: 4+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with a strong focus on post-marketing lifecycle management. Demonstrated experience in preparing and submitting various types of post-approval variations and renewals globally. Proven experience working closely with Pharmacovigilance on safety-related regulatory updates. Solid understanding of global regulatory requirements for marketed products.
• Skills & Competencies: Regulatory Expertise: Comprehensive knowledge of global regulatory requirements (e.g., MHRA, EMA, ICH) pertaining to post-marketing drug product lifecycle. Analytical Skills: Strong analytical and critical thinking skills to interpret complex regulatory guidelines and scientific data. Communication: Excellent written and verbal communication skills, with the ability to effectively articulate regulatory requirements and strategies. Attention to Detail: Meticulous attention to detail in document preparation and review, crucial for compliance. Problem-Solving: Proactive and solution-oriented approach to regulatory challenges in a post-market setting. Independence: Ability to work independently, prioritise tasks, and manage multiple complex projects simultaneously. Team Player: Strong interpersonal skills and ability to collaborate effectively with cross-functional teams.

Why join us?

As well as a fantastic, inclusive company culture, where employees are truly valued and a competitive salary, we also offer an ever-improving benefits scheme to support your physical and mental well-being which include:

• Generous Pension Scheme.
• Life Assurance cover and Employee Assistant Program.
• 25 days’ holiday plus Bank Holidays.
• Learning and Development opportunities.
• Excellent opportunities for progression.
• Fantastic Company events and celebrations throughout the year.