Remote Senior Regulatory Project Lead - Global Submissions

Syneos Health, Inc.; United Kingdom; Remote; GBP 75,000 - 110,000; Full time

Job summary

Syneos Health is seeking a Sponsor Dedicated Regulatory Portfolio Snr. Regulatory Consultant to support a single Sponsor across regions. You will manage regulatory project activities and collaborate with Global Regulatory Affairs to drive timely submissions and approvals.

This role offers remote work with open locations including Spain, Portugal and the UK, leveraging extensive regulatory expertise and leadership to deliver patient-centric therapies worldwide.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs or related field; advanced degree preferred.
• 8+ years of experience in regulatory affairs or project management in pharma/biotech.
• 7–10 years of cross-functional project management experience.
• Expertise in global regulatory submissions; familiarity with FDA, EMA and ICH guidelines.
• MUST have managed multiple marketing applications and/or LCM submissions across regions.
• Must have pharmaceutical development and regulatory global submissions experience.
• Experience with both small molecules and biologics.
• Strong organizational, communication and problem-solving skills; focus on continuous improvement.
• Familiarity with filing submission regions including Europe, UK, Asia Pacific, US, etc.
• Strong PM fundamentals: meeting facilitation, timeline management, risk management.

Responsibilities

• Provide regulatory project management support to a single Sponsor.
• Support Global Regulatory Affairs as part of the Regulatory Project Management Function.
• Lead cross-functional collaboration to ensure timely submissions and approvals.

Skills

PM fundamentals

Timeline management

Risk & issues management

Cross-functional collaboration

Global regulatory submissions

FDA/EMA/ICH guidelines knowledge

Multi-region filings

Regulatory strategy

Regulatory information management

Communication skills

Education

Bachelor’s degree in life sciences/regulatory

Advanced degree preferred

PM/Regulatory certifications (PMP/RAC)

Tools

Smartsheet

ThinkCell

Office Timeline

MS Project

Veeva Vault RIM

Job description

Syneos Health is seeking a Sponsor Dedicated Regulatory Portfolio Snr. Regulatory Consultant to support a single Sponsor across regions. You will manage regulatory project activities and collaborate with Global Regulatory Affairs to drive timely submissions and approvals.

This role offers remote work with open locations including Spain, Portugal and the UK, leveraging extensive regulatory expertise and leadership to deliver patient-centric therapies worldwide.