Regulatory Affairs Specialist

ProductLife Group; Florida; On-site; USD 90,000 - 130,000; Full time

Job summary

ProductLife Group seeks a Regulatory Affairs Manager / Senior Regulatory Affairs Consultant to support medicinal products across UK and EU markets. You will develop regulatory strategies, prepare submissions, and liaise with authorities while mentoring junior staff.

Join a global life sciences consultancy that values accuracy, collaboration, and client-focused delivery to shape successful market authorisations and lifecycle management.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum 5 years in Regulatory Affairs within pharma.
• Experience with UK regulatory requirements and submissions.
• Strong writing and communication skills.

Responsibilities

• Develop regulatory strategies for medicinal products across lifecycle.
• Prepare and manage regulatory submissions (MAAs, variations, renewals).
• Coordinate dossiers per UK/EU requirements and liaise with authorities.
• Draft and review technical docs: modules, SmPC, PIL, labeling texts.
• Mentor junior team members and support project teams.

Skills

Regulatory strategy

Dossier preparation

Regulatory submissions

UK/EU regulations

Client liaison

Project management

Technical writing

Mentoring

Lifecycle management

Education

Bachelor in Life Sciences

Master's degree

Tools

eCTD platforms

ETDM systems

Job description

Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‑thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‑driven work.

Job Description

Job Purpose

The Regulatory Affairs Manager / Senior Regulatory Affairs Consultant is responsible for providing expert regulatory support for medicinal products across the UK and EU markets. The role focuses on developing regulatory strategies, preparing and managing regulatory submissions, ensuring compliance with applicable regulations, and serving as a key point of contact for clients and regulatory authorities. The successful candidate will also mentor junior team members and contribute to the delivery of high-quality regulatory services.

Key Responsibilities

• Develop and implement regulatory strategies for medicinal products throughout their lifecycle.
• Independently prepare and manage regulatory submissions, including new marketing authorization applications, variations, renewals, and responses to regulatory authority questions.
• Compile, review, and coordinate regulatory dossiers in accordance with UK and EU regulatory requirements.
• Write and review technical regulatory documentation, including Module 3 sections, Quality Overall Summaries (QOS), packaging texts, Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and labeling documents.
• Provide regulatory guidance and technical expertise to clients and internal project teams.
• Serve as the primary regulatory contact for clients and liaise directly with regulatory authorities.
• Monitor and assess changes in regulations and advise clients on potential impacts to their products and activities.
• Coordinate and review technical documentation to ensure compliance with regulatory standards.
• Prepare and review user testing readability reports.
• Document, track, and maintain records of regulatory submissions and approvals.
• Support project teams by ensuring regulatory requirements are incorporated into project planning and execution.
• Review work completed by Regulatory Affairs Associates and provide mentoring, coaching, and technical guidance.
• Contribute to systems management and administrative activities related to regulatory operations.
• Deliver high-quality regulatory consultancy services while maintaining strong client relationships.

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline.
• Master's degree or advanced qualification is considered an advantage.

Required Experience

• Minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Strong experience with UK regulatory requirements and procedures.
• Proven experience managing regulatory submissions and lifecycle maintenance activities for medicinal products.
• Experience serving as the primary regulatory contact for clients and health authorities.

Technical Skills

• In-depth knowledge of UK and EU regulatory frameworks and regulatory authorities.
• Strong expertise in regulatory dossier preparation and submission management.
• Experience writing and reviewing regulatory and technical documents.
• Sound understanding of medicinal product lifecycle management.
• Excellent analytical, organizational, and problem-solving skills.
• Strong verbal and written communication skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.

Preferred Qualifications

• Experience in medical writing.
• Previous experience mentoring or supervising junior regulatory professionals.
• Experience working in a consultancy or client-facing environment.
• Familiarity with regulatory information management systems and electronic submission platforms.

Languages

• Fluent English (written and spoken).
• Additional languages are considered an advantage.

Competencies

• Client-focused approach.
• Strong attention to detail.
• Excellent stakeholder management skills.
• Ability to work independently and collaboratively.
• Proactive, organized, and solution-oriented mindset.
• Commitment to quality and continuous improvement.