Regulatory Compliance Specialist - Remote

Job Description:
As a Regulatory Compliance Specialist, you will be working closely with the Manufacturing and Supply teams, and Regulatory CMC colleagues on Vaccines site-based projects to manage change controls, product license commitments and submissions and approvals in key markets and to maintain regulatory compliance for License registrations in existing markets. The Regulatory Compliance Specialist will have responsibility for one or more products or activities in the Vaccines group.

Responsibilities:

• The Regulatory Compliance Specialist will ensure Regulatory compliance by providing support to batch release by checking submission/approvals, ensuring permanent regulatory/license compliance, and reviewing and approving site documents (e.g. Standard Operating Procedures, Site Master File, Product License Commitments).
• The Regulatory Compliance Specialist will manage the review, assessment, and coordination of submission requirements for changes proposed by the M&S organization. Participates in meetings and follow-up activities required to ensure proper assessment of change controls.
• The Regulatory Compliance Specialist manages authoring of CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that support site registrations, specific country documentation, and Annual reports.
• The Regulatory Compliance Specialist prepares responses to Health Authority questions related to CMC from Regulatory affiliates with the contribution of site experts.
• The Regulatory Compliance Specialist may represent on M&S and MSAT project teams when product or valence-related regulatory site expertise is required and serve as the Regulatory interface between M&S, MSAT and GRA.

Required Skills, Experiences, Education and Competencies:

• Bachelor's Degree/Undergraduate Degree. Experience in pharmaceutical/biopharmaceutical industry or related regulatory, industry/manufacturing environment. Well-developed communication skills, both verbal and written.
• Strong authoring skills of GMP and CMC documentation and Health Authority responses
• Ability to manage multiple priorities efficiently
• Ability to resolve strategic technical and regulatory issues
• Should demonstrate initiative, analytical thinking and works independently
• Ability to work well with cross functional teams, and good communication skills with internal and external stakeholders
• Experience working with a Health Authority is helpful but not essential
• Knowledge of global regulations/guidelines, key Health Authority/Industry Guidance and trends are helpful.

The hourly range for roles of this nature are $40.00 to $50.00/hr. Rates are heavily dependent on skills, experience, location, and industry.

cyberThink is an Equal Opportunity Employer.