Regulatory Affairs Coordinator

Duration: 6+ Months

Location: New York, NY

Job Description:

• Ensuring that company databases and systems contain the required information; ensuring compliance as per established processes and SOPs.

• Interact with Company Country Offices Regulatory Teams to work on assigned activities related to Company databases, systems, processes and compliance activities.

• Collaborating with WSR-I and any other stakeholders to collect, organize and populate data in the appropriate databases and systems, as per agreed timelines.

• Generating and compiling reports from numerous sources (e.g. PEARL, PDM and VP) allowing identification of status of submissions and approvals, as per agreed timelines.

• Responsible for routine communication to sponsor and direct manager the progress of the project, and any issues identified. E.g. Weekly/Biweekly check-point meetings to track progress.

• Supporting the WSR-I team with relevant compliance activities, keeping projects on track as per agreed timelines.

• Complete departmental training (e.g. P2L) in a timely manner to address corporate and regulatory needs.

• As applicable, contribute to regulatory initiatives promoting a culture aligned with Company values and which supports compliance and innovation.

Years of experience required?: 3-5 years

Minimum education experience required?: Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science

Please list out the (up to) top 3 critical skills:

• Technical and scientific knowledge of pharmaceutical products

• Understanding different regulatory environments

• Proven ability to support complex regulatory issues and consistently deliver in accordance with the agreed upon timelines, and in alignment with quality standards

• Proficiency in English

• Proficiency in Excel, Power Point and ability to navigate of systems and databases efficiently

• Good communication skills

• Project Management skills

• Ability to problem solve

• Organized

Years of experience required?: 3-5 years

Minimum education experience required?: Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science

Please list out the (up to) top 3 critical skills:

• Technical and scientific knowledge of pharmaceutical products

• Understanding different regulatory environments

•
Proven ability to support complex regulatory issues and consistently
deliver in accordance with the agreed upon timelines, and in alignment
with quality standards

• Proficiency in English

• Proficiency in Excel, Power Point and ability to navigate of systems and databases efficiently

• Good communication skills

• Project Management skills

• Ability to problem solve

• Organized