Senior Regulatory Affairs Consultant - Global Submissions & Strategy

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

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.