Associate Manager Regulatory Operations - US

Job Description

Associate Regulatory Operations 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.). 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.

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).
• 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.
• Works with assistance from Line Manager and guidance from functional mentor to deliver start-up of projects as outlined in the core responsibilities of this document.
• Primarily manages single country or small sized projects

Minimum Qualifications & Experience:

• 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.
• Competent working in virtual teams across time zones.
• Strong presentation, documentation, and people skills.
• High proficiency in English.

The salary range for this position is $110,000 - 145,000 based upon experience. 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 respond to every application. We look forward to contacting you regarding your application.

About Us

Novotech is a global full-service clinical Contract Research Organization (CRO). At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do. Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide. At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients. With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.

About the Team

At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences. At Novotech you will work alongside empowered teams with a shared commitment to success. * Strategic vs transactional mindset. * Ability to gain insights and make proactive decisions quickly. * Culture that fosters partnership and collaboration, where every voice is heard and valued. * Ongoing support from senior stakeholders and leadership team. .