Sr Reg Affairs Spec

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
This a client dedicated role for a Regulatory Affairs Specialist role.
Job Purpose
Works closely with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), global submission teams and Local Operating Company regulatory contacts to deliver submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with client's SOPs and working practices.
Mentors/coaches/trains other team members and reviews work to ensure right first-time submissions.
Key responsibilities
- Prepares and reviews regulatory submissions.
Provides regulatory strategy and/or technical advice to internal and external

clients, and acts as a liaison in executing strategies.
Leads the development and implementation of project-specific processes for sponsors.
Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all
aspects of contract modifications.
Provides training and guidance to junior team members as appropriate.
Participates in project launch meetings, review meetings and project team
meetings.
Supports business development activities, including project
budgeting/forecasting
**Education Requirements**
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
5+ years).

**Working Conditions and Environment**:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.