Regulatory Affairs Manager
Regulatory Affairs Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Oversee the preparation and review of dossiers and documents ensuring timely renewal of facilities and product licenses in the US Canada and other countries.
- Monitor regulations by FDA Health Canada COFEPRIS ANVISA and others designing strategies for compliance with new and existing regulations.
- Create motivate lead and evaluate small to midsize teams to achieve department and corporate goals.
- Work with the Director in budgeting regulatory strategy goal setting and motivation of team members.
- Coordinate crossfunctional teams and consultants managing the regulatory team and organizing weekly meetings for tracking RA projects and tasks.
- Strategic Planning and Implementation:
- Assist the Director in managing and leading strategy formulation and implementation to create greater efficiency and improve regulatory processes.
- Organize regulatory strategies into PowerPoint presentations and reports for the RA Director and other GCA/GCIAG executives.
- Communication and Coordination:
- Organize and moderate weekly departmental meetings.
- Communicate feedback from the RA team to the Director and other stakeholders.
- Coordinate RA team to work with QA and Marketing teams to ensure updated QMS and regulatory compliance of marketing promotional materials.
- Operational and Vendor Management:
- Support the Director of Regulatory Affairs in vendor relationship management and evaluation of proposals prior to Director approval.
- Work with Legal to ensure NDAs with third parties are up to date.
- Manage the crossfunctional team responsible for the preparation of dossiers for regulatory submission overseeing documentation formatting and maintenance within the documentation management system.
Requirements:
- A minimum of a bachelors degree in a science field required.
- Experience in Management and Regulatory Function in Pharma Device or Healthcare.
- Experience in Management and Regulatory Affairs.
- US and Global Managerial and Regulatory experience Leadership P&L experience.
- Experience with FDA and Other US regulatory bodies required.
Employment Type
Full Time
