Associate Manager Regulatory Operations - US

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 escalate 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).

Qualifications

• Graduate in a clinical, pharmacy or life sciences related field.
• At least 5 years' experience from a CRO, biotech, or the pharmaceutical industry.
• Activities related to trial start-up and/or regulatory operations.
• Through knowledge of applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• Certain competence working in virtual teams across time zones.
• Strong presentation, documentation, and people skills.
• High proficiency in English.

Pay

The salary range for this position is $110,000 - 145,000 based upon experience.

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 of the things that is 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. We are a Circle Back Initiative Employer and commit to responding to every application. We look forward to contacting you regarding your application.