Team Leader - Compliance Training responsible for designing and developing compliance training programs in financial services. Leading a team and managing training implementation activities in India.
About the role
- Regulatory Professional at Novo Nordisk managing clinical trial submissions in the EU. Driving coordination of tasks and working with multiple stakeholders across Denmark, Poland, and India.
Responsibilities
- Play a crucial role in driving, coordinating, and actively following up on multiple tasks with challenging timelines.
- Working on process optimisation for CTA submissions within a team and stakeholders from other teams.
- Working closely with various submission teams across the organization and all countries in Europe.
- Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation (EU CTR) and all changes during the life cycle of clinical trials.
- Maintaining documents in the Clinical Trial Information System (CTIS) and ensuring accurate data about clinical trials.
- Coordinating responses for requests for information from Health Authorities and Ethics Committees.
- Ensuring timely submissions in CTIS and contributing to project team decisions.
- Shaping the future setup of new processes for submitting Clinical Trial Applications (CTAs).
- Collaborating with different IT platforms, such as Veeva Vault RIM and Vault Clinical (COSMOS).
Requirements
- Master’s degree in life science or relevant field.
- + 5 years of experience in working with clinical trials and submissions.
- EU Clinical Trial Regulation 536/2024 (EU CTR) understanding and experience.
- Experience in working with Vault RIM and Vault Clinical (Veeva platforms), it’s a plus.
- Experience working with Clinical Trial Information System (CTIS) (how to upload documents and knowledge of full CTIS structure for Part I and part II) – is a big advantage.
- Fluency in written and spoken English.
- Experience with improvement of work flows/optimisation projects.
Benefits
- Opportunities to learn and develop
- Inclusive recruitment process and equality of opportunity for all job applicants
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Regulatory Toxicologist supporting clients on product registrations, toxicological evaluations, and risk assessments in the chemical sector. Join a leading sustainability consultancy with a focus on agrochemicals.
Consultant GRC confirmed assisting clients in strategic aspects of cybersecurity. Working on risk analysis and compliance with standards in a hybrid role in Courbevoie.
Solution Owner overseeing Trackwise systems for regulatory and quality solutions at Convatec. Balancing technical expertise with strategic vision to optimize processes and maintain system integrity.
Digital Communications Surveillance Analyst at S&P Global Ratings monitoring electronic communications for regulatory compliance. Collaborating with global teams and identifying potential compliance issues.
Senior Director overseeing Quality & Regulatory Strategy for innovative medical device company. Partnering with executives to drive compliance and operational excellence in a regulated environment.
Risk & Compliance Manager overseeing compliance frameworks at Plenti, a growing fintech lender. Bridging regulatory compliance and operational risk to support sustainable growth.
Compliance Testing Manager responsible for planning and executing compliance testing and validations. Leading specialist teams while ensuring regulatory compliance in the U.S. banking sector.
Senior Business Management Specialist leading significant compliance strategy and governance activities for TD Bank. Managing risk and oversight processes while collaborating across multiple functions.
Senior Information Security Analyst ensuring compliance and data privacy at VERO. Involved in governance, risk management, and promoting security culture.