Regulatory Affairs Manager

i-Pharm ConsultingGruppe; United Kingdom; Remote; GBP 60,000 - 100,000; Full time

Job summary

A consulting firm is looking for a Regional Regulatory Lead to oversee regulatory submissions and manage cross-functional teams. Candidates should have advanced degrees and extensive experience in regulatory affairs. The role requires strong analytical and project management skills, and the ability to navigate various health authorities' regulations effectively. Flexibility to handle different projects is essential. Remote work is an option.

Qualifications

• Experience leading regulatory submissions and projects is strongly preferred.
• Experience with therapeutic areas across various stages of drug development.
• Advanced knowledge of ICH guidelines and global regulatory standards.

Responsibilities

• Lead Regulatory Submission Teams and manage regulatory strategies.
• Prepare and file regulatory submissions for commercial or investigational products.
• Guide teams in authoring regulatory documents.

Skills

Regulatory requirements knowledge

Analytical skills

Project management

Interpersonal skills

Education

PharmD/PhD

MA/MS/MBA

BA/BS

Tools

Microsoft Office

Job description

In this role, you will typically act as the Regional Regulatory Lead for assigned products, compounds, indications, or projects within a designated therapeutic area. You will lead Regulatory Submissions Teams and represent Global Therapeutic Area Regulatory on cross-functional sub-teams. Responsibilities include managing regulatory strategies and submissions, providing guidance to less experienced team members, and ensuring compliance with applicable regulatory requirements. You may also serve as a point of contact for interactions with regulatory authorities.

Key Responsibilities

• Serve as the Regional Regulatory Lead on cross-functional and cross-regional Regulatory Submission Teams.
• Participate in other sub-teams such as Clinical, Nonclinical, Biomarkers, or Study Management teams.
• Identify regulatory or related risks/issues proactively and develop mitigation or contingency plans.
• Lead the preparation, compilation, and timely filing of regulatory submissions for commercial or investigational products (e.g., meeting requests, briefing packages, INDs, DSURs, IB updates).
• Guide cross-functional teams in the authoring of regulatory documents including Module 1 content and meeting packages.
• Provide input into original labels and label updates.
• Ensure product packaging and associated information is maintained in line with product licenses across assigned markets.
• Critically review documents submitted to regulatory authorities.
• Contribute to process improvements and special projects within Regulatory Affairs.
• May manage direct reports and coach less experienced colleagues.
• Ensure compliance with internal practices, policies, processes, and applicable regulatory requirements.

Qualifications & Requirements

Education & Experience (U.S.):

• PharmD/PhD with relevant experience.
• MA/MS/MBA with 4+ years of relevant experience.
• BA/BS with 6+ years of relevant experience.
• Experience leading regulatory submissions and projects is strongly preferred.
• Experience in process writing or updates and working within project teams.
• Experience with therapeutic areas across various stages of drug development is an advantage.

Education & Experience (Rest of World):

• BA/BS or advanced degree in life sciences or a related field, with significant experience in regulatory affairs or a related field (e.g., clinical research, healthcare, or regulatory agency).

Knowledge & Skills:

• Quick learner with the ability to adapt to new situations and responsibilities.
• Flexible and responsive to change; able to shift between projects and priorities effectively.
• Advanced knowledge of regulatory requirements, ICH guidelines, and global regulatory standards.
• Understanding of relevant health authorities, including systems, processes, and submission requirements.
• Strong analytical, writing, and communication skills.
• Proficient in project management and Microsoft Office tools.
• Proven leadership and influence in cross-functional programs or initiatives.
• Strong interpersonal skills and ability to work effectively in a matrixed, team-oriented environment.
• Willingness and ability to travel as needed.

If you are interested in finding out more about this role or others, please contact Sharleney Chandraratna at [e-mail] or call: [phone]

• Location Melbourne, Victoria, Australia (Remote)
• Perth, Western Australia, Australia (On-site)