Remote UK: Global Regulatory Affairs Manager

MMS Holdings Inc; Belfast City District; Remoto; GBP 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

MMS Holdings Inc is a data-focused clinical research organization actively seeking a Regulatory Strategy professional for UK remote work. The role emphasizes regulatory submissions, global coordination, and strategic guidance across regions to ensure compliant drug development processes.

The candidate will guide i) regulatory documents and responses, ii) submission strategies per evolving guidance, and iii) post‑approval updates, with strong communication and MS Office proficiency.

Competenze

• Maintains deep knowledge of regulations and ICH guidelines.
• Proficient in MS Office, Adobe Acrobat, and SharePoint.
• Oversees regulatory submissions and project deliverables.
• Experience with eCTD submissions and regional variations.
• Strong communication and problem-solving skills.

Mansioni

• Regulatory strategy oversight for submissions.
• Lead strategic guidance for regulatory documents and responses.
• Coordinate across regions for submissions and queries.
• Manage project plans and timelines to ensure on-time delivery.
• Provide input on annual reports and post-approval updates.

Conoscenze

Regulatory strategy

ICH guidelines

MS Office

SharePoint

SAS viewer

eCTD process

Global submissions

Project management

Regulatory writing

Descrizione del lavoro

MMS Holdings Inc is a data-focused clinical research organization actively seeking a Regulatory Strategy professional for UK remote work. The role emphasizes regulatory submissions, global coordination, and strategic guidance across regions to ensure compliant drug development processes.

The candidate will guide i) regulatory documents and responses, ii) submission strategies per evolving guidance, and iii) post‑approval updates, with strong communication and MS Office proficiency.