About the role

Regulatory Affairs Specialist responsible for regulatory submissions for clinical trials and marketing. Collaborates with internal and external stakeholders under senior guidance.

Responsibilities

Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff;
Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate;
Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters;
Understands the Scope of Work, deliverables for any given project;
May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person;
May prepare and deliver trainings, as appropriate;
Performs other tasks or assignments, as delegated by Regulatory management;
Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex;

Bachelor's Degree in Lifescience or related discipline.
At least 2 years of regulatory affairs (postmarketing) experience: maintenance records, new records, regulatory activities.
Fluent English : Spoken, Read and Written.
It's a plus to have worked with other countries: USA, Canada.
Good, solid interpersonal communication (oral and written) and organization skills;
Ability to establish and maintain effective working relationships with coworkers, managers and clients;
Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
Demonstrates self-motivation and enthusiasm;
Ability to work on several projects, with direction from senior staff as appropriate;
Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
Ability to make decisions on discrete tasks under senior supervision;
Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.