Associate Regulatory Start Up Manager

Brief Position Description

The Associate Regulatory Start Up Manager 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.

Minimum Qualifications & Experience

• Graduate in a clinical, pharmacy or life sciences related field.
• At least 3 years' experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations. Involvement in more than one country start-up activities and submissions coordination will be an asset.
• Through knowledge of CTR 536/2014 and other applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• Strong presentation, documentation, and people skills. Previous direct cooperation with clients will be an assent.
• High proficiency in English.

Responsibilities

• Define a project 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.
• Proactively identify any risks to start-up and elevate to Project Manager.
• 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 planned approval timelines.
• Oversee site activation package compilation and approvals.
• Provide timely update of regulatory start-up progress to Project Manager and clients.
• 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.

Associate Regulatory Start-Up Manager (ARSM)

This role is for individuals who are new to the role of Project Manager or Regulatory Operations Manager or other leadership role within the CRO industry.

• Essential training in the areas of customer service, project management skills and regulatory and start-up technical skills will be provided at commencement of the position.

Benefits

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only a part of the things that are important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.