job summary: Job Summary
This position focuses on the management of CMC regulatory activities for an enzyme substitution therapy program for domestic and international regulatory affairs. The role involves working closely with in-house CMC teams, partners, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applications, amendments, supplements/ variations, and other CMC-oriented filings.
location: San Rafael, California
job type: Contract
salary: $30.40 - 35.76 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- Oversee planning, preparation, and submission of the CMC sections of marketing applications globally.
- Ensure that the sections are accurate, complete, well-written, and meet all relevant country-specific requirements.
- Develop excellent relationships with internal functional groups, contract manufacturing organizations, and partners.
- Researching and interpreting global CMC regulations and providing regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups.
- This position is also responsible for obtaining and interpreting CMC regulations and guidance and providing regulatory advice to technical operations departments.
qualifications: Education & Qualifications
- 5+ Years Experience with Bachelor's degree in chemistry, biology, biochemistry or related field.
- Understanding of ICH guidance's and CMC regulations.
- Expertise with biologics and/or drug/biologic/device products is strongly preferred.
- Strong communication and management skills are required.
- Excellent organization skills.
- Attention to detail.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
skills: CMC, Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions, ICH Regulations
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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.