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 position operates within the North American regulatory landscape, navigating diverse intercultural contexts.
- The Regulatory Affairs Project Specialist will collaborate with various stakeholders, fostering effective communication and understanding across regional regulatory frameworks.
- Manage 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.
- This position is vital to ensuring the timely and high-quality delivery of the carve-out project, making a significant impact on the overall success of the regulatory affairs team.
Requirements:
- Bachelor's degree in Administration, Engineering, Life Sciences, or a related field.
- Planning and organizational skills to manage multiple projects simultaneously
- Communication skills to effectively interact with diverse stakeholders
- Result-oriented mindset with a proactive approach to problem-solving
- Minimum of 5 years of experience in regulatory affairs in the US and Canada and/or project management and/or administrative functions, with a demonstrated ability to navigate complex projects.
- 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.
- Dossier experience
- Time Management skills
Benefits: Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics. Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st. Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification. Synectics is an equal opportunity employer.