Regulatory Affairs Manager
Posted Today by i-Pharm Consulting
Negotiable
Undetermined
Remote
England, United Kingdom
Summary: The Regulatory Affairs Manager will act as the Regional Regulatory Lead for assigned products within oncology, specifically focusing on lung, GI, and GU indications. This role involves leading regulatory submissions teams, managing regulatory strategies, and ensuring compliance with regulatory requirements. The position requires experience in global submissions and people management, with a strong emphasis on collaboration across various functional teams. The role is remote and based in the UK, with a contract duration of 18 months.
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.
- 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.
Key Skills:
- PharmD/PhD or relevant degree with experience in regulatory affairs.
- MA/MS/MBA with 4+ years or BA/BS with 6+ years of relevant experience.
- Experience leading regulatory submissions and projects.
- Advanced knowledge of regulatory requirements, ICH guidelines, and global regulatory standards.
- 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.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Job Title: Regulatory Affairs Manager
Location: Remote (UK Based)
Contract: 18 Months
Must have experience with: Submissions (Global incl. US) Oncology, indications – Lung, GI & GU People management experience
Position Overview
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