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

Competitive Salary & Company Benefits. Ideally located close to Petersfield or Leicestershire. We will also be considering applications from people in India. Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day).

Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients’ lives across the world? 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: We are currently looking to recruit a Principal Regulatory Affairs Executive, Lifecycle Management & Post-Marketing Compliance for our Regulatory Affairs department. You will be responsible for leading and executing complex post-approval regulatory activities for the company's marketed products. This role is responsible for managing 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.

What will you be doing?

• Lead the preparation, compilation, and submission of all types of post-approval variations (e.g., quality, safety, administrative changes) to relevant global regulatory authorities.
• Manage the timely preparation and submission of product renewals, ensuring all required documentation and data are submitted in accordance with regional regulations.
• Coordinate and prepare regulatory submissions for safety updates in close collaboration with Pharmacovigilance.
• Coordinate and prepare responses to regulatory authority questions arising from post-approval submissions, ensuring timely and accurate responses.
• Provide regulatory support for out-licensing activities, including the transition of regulatory responsibilities and documentation.
• Monitor and interpret new and evolving post-marketing regulations, guidelines, and health authority communications.
• Assess their impact on existing products and recommend appropriate actions.
• Contribute to the development and maintenance of internal regulatory policies and procedures related to post-marketing compliance and lifecycle management.

Collaboration & Communication:

• Act as a key regulatory contact for the Pharmacovigilance team, ensuring seamless communication and coordination for all safety-related regulatory activities.
• Act as a key regulatory contact for internal teams (including Quality Assurance, Supply Chain, and Commercial teams) and external partners to ensure variation & renewals information meets regulatory requirements for ongoing supply.
• Provide support for interactions with regulatory authorities on post-approval matters, including discussions related to variations, renewals, and compliance issues.
• Mentor and provide guidance to junior regulatory team members, assisting in their development and understanding of lifecycle management processes.
• 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.
• Manage the accurate and compliant translation of post-approval regulatory documents, coordinating with external vendors as needed.

The Person:

• Regulatory Knowledge: Strong technical understanding of pharmaceutical development, manufacturing processes, and quality control.
• Analytical Thinking: Ability to critically evaluate scientific data and regulatory documents.
• Communication: Strong written and verbal communication skills.
• Attention to Detail: Meticulous attention to detail and accuracy in all work.
• Problem-Solving: Proactive in identifying and resolving regulatory issues.
• Collaboration: Ability to work effectively within a team and across functional boundaries.

Education:

• Required: Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline is required.
• Preferred: Master's degree or Ph.D. in a relevant scientific field or Regulatory Affairs is preferred.

Experience:

• Proven experience in Regulatory Affairs within the pharmaceutical industry, with a primary focus on CMC.
• A track record of writing and reviewing Module 3 and Module 2.3 sections for a variety of regulatory submission types (e.g., IND, NDA, BLA, MAA).
• Solid understanding of global CMC regulatory requirements (e.g., ICH, MHRA, EMA, FDA) and GMP principles.
• Proven experience in managing post-approval CMC variations and amendments.
• Experience in interacting with cross-functional teams (R&D, Quality and CDMOs).

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:

• Company pension scheme.
• Life Assurance cover and Employee Assistance Program.
• 25 days’ holiday plus bank holidays.
• Learning and development opportunities.
• Excellent opportunities for progression.
• Fantastic company events and celebrations throughout the year.