Job Title: Regulatory Affairs Project Specialist
Job Description

The Regulatory Affairs Project Specialist will play a crucial role in supporting the regulatory affairs team during the Carve-out project in North America. This position will ensure that the regulatory activities are executed efficiently, aligning with project timelines and compliance standards. This role operates within the North American regulatory landscape, navigating diverse intercultural contexts and fostering effective communication across regional regulatory frameworks.

ResponsibilitiesManage project prioritization and execution for the carve-out initiative, ensuring alignment with regulatory timelines and deliverables.Coordinate state and federal registration projects, streamlining processes and ensuring compliance with regional requirements.Prepare and oversee label documentation, ensuring accuracy and regulatory adherence throughout the preparation process.Interact with internal and external stakeholders, serving as a liaison to facilitate effective communication and collaboration until dossier submissions and approvals are achieved.Support the regulatory affairs team in coordinating activities related to the due diligence process, ensuring thorough evaluation and documentation.Evaluate and improve regulatory processes to enhance efficiency and compliance, contributing to overall project success.Participate in cross-functional meetings to influence project outcomes and address regulatory challenges proactively.Execute administrative functions as needed, maintaining meticulous records and documentation to support project transparency and accountability.Essential SkillsBachelor's degree in Administration, Engineering, Life Sciences, or a related field.Minimum of 5 years of experience in regulatory affairs in the US and Canada and/or project management and/or administrative functions.Strong team working skills and the ability to operate independently.Excellent communication skills, both written and verbal, to effectively interact with diverse stakeholders.Result-oriented mindset with a proactive approach to problem-solving.Initiative and the ability to prioritize tasks effectively.Exceptional planning and organizational skills to manage multiple projects simultaneously.Additional Skills & QualificationsExperience with label documentation and regulatory adherence.Familiarity with regulatory documents in the food industry, pharmaceutical, and cosmetic sectors.Work Environment

This is a remote position with a schedule of Monday to Friday business hours. The role involves interacting with diverse stakeholders across North America and requires effective communication and collaboration within a virtual environment.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.