Senior Manager, RA Submissions
Senior Manager, RA Submissions at Johnson & Johnson Innovative Medicine
Location: London, United Kingdom
Job Overview
We are seeking an experienced Senior Manager to lead the CTA team in the UK, overseeing regulatory submissions and supporting team development.
Key Responsibilities
- Lead and oversee a CTA team in planning, preparing, and maintaining regulatory submissions and filings, ensuring accuracy and compliance.
- Manage all HR-related processes for the team, including performance management, development, and fostering a positive work environment.
- Drive the coaching and professional development of team members, promoting continuous improvement and a high-performance culture.
- Maintain and promote up-to-date expertise on global and regional regulations.
- Provide leadership and oversight to the CTA team, ensuring application of appropriate regulatory submission standards.
- Analyze team workload, prioritize assignments, and oversee tracking of submission activities using relevant systems.
- Lead the development and alignment of submission operational strategies with overarching regulatory strategies.
- Drive continuous improvement by leading development of departmental work practices, processes, and workflows.
- Actively participate in CTA leadership team meetings.
- Ensure open, timely communication with all stakeholders.
- Foster strong collaborations with key partners to proactively resolve conflicts and remove obstacles.
Job Requirements
- Strong leadership capabilities with proven experience in managing direct reports.
- Proven understanding of regulatory requirements related to Clinical Trial Applications, including ICH‑GCP, EMA, and other guidelines.
- Demonstrated experience leading preparation, review, and submission of CTAs.
- Exceptional analytical skills.
- Effective verbal and written communication skills.
- Bachelor’s Degree or higher in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
- Strong organizational skills and ability to manage multiple submissions and deadlines.
- Ability to work or lead in a matrix environment.
Education and Experience
- Bachelor’s degree and 8‑10 years overall experience (required).
- 7+ years relevant industry experience; Masters/Pharm D/PhD with 6+ years preferred.
- People or team management experience required.
- Global CTA regulations knowledge required.
- Project leadership experience required.
- Prior senior leadership experience preferred.
Required Skills
- Compliance Management
- Cross-Functional Collaboration
- Design Thinking
- Developing Others
- Inclusive Leadership
- Leadership
- Operational Excellence
- Package and Labeling Regulations
- Process Improvements
- Risk Assessments
- Strategic Thinking
- Team Management
EEO Statement
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Accommodation Request
If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
