Associate Manager Regulatory Operations - US

Novotech Global•Charleston, SC

8d•$110,000 - $145,000

About The Position

The Associate Regulatory Operations Manager is primarily responsible for planning, driving, and coordinating operational aspects of regulatory and start-up across a region. This role partners with the Project Manager to ensure project deliverables are met within agreed project timelines and in accordance with client expectations. This role is ideal for individuals new to leadership roles within the CRO industry, such as Project Manager or Regulatory Operations Manager. Essential training in customer service, project management skills, and regulatory and start-up technical skills will be provided at the commencement of the position. Novotech is a global full-service clinical Contract Research Organization (CRO) with a commitment to fostering an environment that reflects the life-changing work they do. They have expanded their global footprint with 30+ offices across Asia-Pacific, the United States, and Europe, uniting professionals from diverse backgrounds to advance therapies. Novotech offers trust, flexibility, and autonomy through programs like NovoLife, empowering team members to create an effective work-life balance. Employees have access to mentorship opportunities, professional development programs, and a dynamic community to achieve personal growth while shaping the future of healthcare.

Requirements

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.

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