Global Regulatory Affairs (CMC) | Contract

job summary: Global Regulatory Affairs (CMC) Consultant Remote (US based) | 6 month Contract reputed company: $95-$115/hour (W2 only, DOE) Under the direction of the Director of Regulatory Affairs, reputed company 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 reputed company 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.
• reputed company regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that reputed company applicable regulatory requirements are considered and appropriately incorporated into submissions for marketing authorizations.
• reputed company 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 reputed company 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.
• reputed company CMC regulatory guidance to project / product teams.

qualifications:

• B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology or reputed company 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.
• LI-AT1

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, reputed company, Religion, Sex, Sexual Orientation, Gender Identity, National reputed company, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At reputed company, we welcome people of reputed company abilities and want to ensure that our hiring and interview process meets the needs of reputed company applicants. If you require a reasonable accommodation to reputed company your application or interview experience a great one, please contact [email protected]. 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, reputed company offers a comprehensive benefits package, including: medical, prescription, dental, reputed company, AD&D, and life insurance offerings, short-term disability, and a 401K plan (reputed company benefits are based on eligibility). This posting is reputed company for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply tot his job Apply To this Job