Jobs in Manchester, United States

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 schandraratna@i-pharmconsulting.com or call: +44 (0) 2075510732

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