Regulatory Start Up Manager

Novotech; Poland; On-site; PLN 260,000 - 340,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Flexible leave entitlements

Wellness programs

Ongoing professional development and培训

Mentoring and career development

Collaborative global environment

Job summary

Novotech is seeking a Regulatory Start Up Manager in Poland to lead regulatory start-up activities across regions, aligning with the project manager to meet timelines and client expectations. You will develop RSU strategies, manage document customization, ensure submissions to health authorities, and coordinate with local teams to deliver on scope while maintaining regulatory compliance.

Join a global CRO offering flexible working options, ongoing professional development, and a collaborative,

Qualifications

• Graduate in a clinical, pharmacy or life sciences field.
• 3+ years CRO/pharma start-up/regulatory operations experience.
• Thorough knowledge of applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• High proficiency in English.

Responsibilities

• Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan.
• Oversee the execution of regulatory start up for assigned projects in accordance with RSU strategy.
• Coordinate with local regulatory start up teams to deliver the agreed project scope on time and in compliance with the RSU plan.
• Oversee submission processes to health authorities and ethics committees; coordinate approvals regionally.
• Maintain CTMS and regulatory databases; provide progress updates to project manager.
• Deliver presentations and training to clients and stakeholders about regulatory start up activities.

Skills

Regulatory knowledge

Matrix management

Decision-making

Presentation skills

English proficiency

Education

Life sciences degree

Job description

The Regulatory Start Up Managers (RSM) is primarily responsible to plan, drive and coordinate operational aspects of regulatory and start-up across a region, by partnering with the Project Manager to ensure project deliverables are met within agreed project timelines and in accordance with client's expectations.

Responsibilities

• Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan.
• Oversee the execution of regulatory start up for assigned projects in accordance with agreed RSU strategy.
• Ensure collaboration with local regulatory start up teams to successfully deliver the agreed project scope in compliance with the RSU management plan.
• Distribute start up related documents to local regulatory start up teams.
  • Oversee customization of core start-up documents to local requirements.
  • Ensure preparation and distribution of core contract and budget templates to applicable team members.
  • Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines.
  • Oversee site activation package compilation and approvals.
• Proactively identify any risks to start up and elevate to Project Manager. Develop RSU mitigation plans.
• Provide timely update of regulatory start up progress to Project Manager.
• Present at external and internal meetings including but not limited to project internal and external meetings, kick-off meetings.
• Serve as a client's contact for regulatory start up related items.
• Support business development by providing relevant information on regulatory start-up and attending Bid Defenses to present Novotech's regional capabilities.
• Ensure accurate completion and maintenance of internal systems including CTMS, relevant databases, and tracking tools.
• Deliver presentation/training to clients and internal/external stakeholders regarding regulatory start up activities.
• Facilitate cooperation between cross-functional teams.
• Contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence.
• Identify areas of inefficiency in regulatory start up process and make recommendation for improvements.
• Represent Novotech at Industry fora (conferences, professional association, committee work, international investigator meetings).
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.

Qualifications

• Graduate in a clinical, pharmacy or life sciences related field.
• 3+ years of experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations.
• Thorough knowledge of applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• Strong presentation, documentation, and people skills.
• High proficiency in English.

Salary Band - RSM : PLN 260,000 - 340,000. Salary offered will be based on the candidate's experience level.

Why Novotech?

At Novotech, we are committed to creating an inclusive workplace where everyone is treated fairly and with respect.

Our employees are passionate about the work we do, while recognising the importance of maintaining a healthy balance between work and life.

We support our employees through:

• Flexible working options
• Paid parental leave for both parents
• Flexible leave entitlements
• Wellness programs
• Ongoing professional development and training
• Mentoring and career development opportunities
• A collaborative and supportive global environment

About Novotech

Novotech is a global full-service Contract Research Organization (CRO) providing clinical research and scientific advisory services to the biotechnology and pharmaceutical industries.

Since 1997, we have expanded our global footprint to 30+ offices across Asia-Pacific, the United States and Europe. Our diverse teams work together to advance therapies that improve patient outcomes worldwide.

At Novotech, ambition meets opportunity. We combine advanced therapeutic and regulatory expertise with a client-centric service model, giving our employees the opportunity to work with innovative life sciences companies and develop their careers within a supportive global organisation.

Our culture is built around:

• Strategic thinking and a proactive mindset
• Partnership and collaboration
• Empowered teams and shared accountability
• Open communication where every voice is heard and valued
• Ongoing support from senior stakeholders and leadership

Join Novotech and be part of a team helping bring life-changing therapies to patients faster.