Regulatory Affairs Coordinator

Company Description Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at http://www.mindlance.com. Job Description 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

Qualifications

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