Global Regulatory Affairs Associate Director (Cardio-Metabolic)

Novartis; Greater London; Hybrid; GBP 70,000 - 95,000; Full time

Job summary

A leading pharmaceutical company is seeking a Senior Global Program Regulatory Manager to lead regulatory strategies and operational activities. The ideal candidate will have extensive experience in regulatory affairs, a strong background in project management, and excellent problem-solving skills. Fluency in English is essential. This role is based in London with a hybrid working model. Responsibilities include managing submissions, ensuring compliance, and overseeing Health Authority interactions to expedite regulatory approvals.

Qualifications

• Significant experience in regulatory affairs within the pharmaceutical industry.
• Proven track record in project management and regulatory operations.
• Fluency in English (written and spoken) is essential.

Responsibilities

• Lead the implementation of regulatory strategies and operational activities across major global regions.
• Align regional regulatory approaches with global objectives through collaboration.
• Develop and implement strategies to minimize review delays and regulatory clock stops.
• Define and manage Health Authority interaction strategies including preparation of briefing materials.
• Oversee the planning coordination and submission of regulatory dossiers.

Skills

Clinical Trials

Cross-Functional Teams

Detail-Oriented

Drug Development

Lifesciences

Negotiation Skills

Problem Solving Skills

Regulatory Compliance

Risk Management

Education

Bachelors or Masters degree in Life Sciences, Pharmacy, or a related field

Tools

Adobe Acrobat

Job description

Job Description Summary

#LI-Hybrid (12 days per month on-site)

Location: London (The Westworks) United Kingdom or Dublin Ireland

Internal Job Title: Global Program Regulatory Associate Director

We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs role involves directing the development and submission of regulatory documents providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products and serves as a regulatory liaison throughout the product lifecycle.

Job Description

Major accountabilities

• Lead the implementation of regulatory strategies and operational activities across major global regions.
• Provide strategic input into global regulatory plans identifying risks and contributing to key planning documents.
• Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams.
• Define and manage Health Authority (HA) interaction strategies including preparation of briefing materials.
• Oversee the planning coordination and submission of regulatory dossiers (e.g. CTAs INDs Risk Management Plans).
• Serve as a liaison with local HAs (e.g. FDA EMA) and lead or support negotiations for regional approvals.
• Develop and implement strategies to minimize review delays and regulatory clock stops.
• Ensure timely and compliant responses to HA queries and requests.
• Contribute to departmental goal setting and lead initiatives to improve regulatory processes.
• Ensure adherence to internal policies SOPs and global regulatory requirements.

Minimum requirements

• Bachelors or Masters degree in Life Sciences Pharmacy or a related field.
• Significant experience in regulatory affairs within the pharmaceutical industry.
• Proven track record in project management and regulatory operations.
• Experience representing the organization in cross-functional and cross-cultural settings.
• Strong knowledge of clinical trials drug development and regulatory compliance.
• Excellent problem-solving negotiation and communication skills.
• Detail-oriented with the ability to manage complex regulatory projects.
• Skilled in risk management and working with cross-functional teams.
• Ability to navigate and influence Health Authority interactions.
• Fluency in English (written and spoken) is essential.

Commitment to Diversity and Inclusion / EEO

Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired

• Clinical Trials
• Cross-Functional Teams
• Detail-Oriented
• Drug Development
• Lifesciences
• Negotiation Skills
• Problem Solving Skills
• Regulatory Compliance
• Risk Management

Required Experience

Director

Key Skills

• Proofreading
• Adobe Acrobat
• FDA Regulations
• Manufacturing & Controls
• Biotechnology
• Clinical Trials
• Research & Development
• GLP
• cGMP
• Product Development
• Chemistry
• Writing Skills

Employment Type: Full-Time

Experience: years

Vacancy: 1