Global Regulatory Affairs (CMC) Consultant
Remote (US based) | 6 month Contract
Rate: $95-$115/hour (W2 only, DOE)
Under the direction of the Director of Regulatory Affairs, lead and manage Regulatory CMC activities focused on the development of a Core Dossier for Module 3 and the preparation of high-quality Module 3 documents to support global regulatory submissions. This role requires deep expertise in biologics and strategic regulatory leadership across development, manufacturing, and global health authority engagement.
MUST HAVE
- Degree in Biochemistry, Chemistry, Biology, or related field
- Provides strategic Regulatory CMC guidance to cross-functional teams
- Experience leading regulatory interactions with US/EU Health Authorities
- Expertise authoring Module 2/3 doc for global regulatory submissions
- Strong Biologics background
location: Telecommute
job type: Contract
salary: $95 - 115 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Provied support to Health Authority interactions.
- Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into submissions for marketing authorizations.
- Provide Reg CMC support for development programs to ensure that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned.
- Manage preparation of submissions to applications in a timely manner to meet corporate objectives.
- Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives.
- Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines.
- Provide CMC regulatory guidance to project / product teams.
qualifications:
- B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field.
- Minimum of 4 years experience in pharmaceutical product development including significant experience in CMC regulatory affairs with a strong biologics background.
- Experience in directing interactions with regulatory authorities.
- Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance.
- Significant coordination with cross-functional teams internally and regulatory authorities externally.
skills: Regulatory Affairs Strategy, Biologics, Regulatory Compliance, European Medicines Agency (EMA), Biologics License Application (BLA), FDA Submissions, Chemistry Manufacturing and Controls (CMC), Health Authority Interaction Management, Global Regulatory Strategy Execution
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
