Senior Manager(CMC Regulatory Affairs Biologics) - Integrated Resources, Inc
Foster City, CA 94404
About the Job
Job Title: Senior Manager(CMC Regulatory Affairs – Biologics)
Job Location: Foster City, CA
Job Duration: 6 Months+ (Possible extension)
Pay range: $100/hr. on W2
Job Description:
• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. Ensure dossiers meet ICH and local regulatory requirements.
• Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the International markets.
• Liaise with colleagues in Regulatory Affairs therapeutics teams, Client local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
• Co-ordinate regulatory assessments for post-approval CMC changes, develop filing strategy and plans for assigned markets and execute filings according to agreed priorities.
• Maintain a current awareness of CMC registration requirements in each of the International regions and communicate key regulatory intelligence to the organization on a timely basis.
KNOWLEDGE, EXPERIENCE AND SKILLS
• BA/BS, MS or Ph.D or equivalent education.
• Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience.
• Experience in the preparation of CMC components of MAA or post-approval variation submissions for small molecule and/or biologics products.
• Biologics experience or drug-device combination product experience would be an advantage.
• A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
• Proven strategic thinking skills, with a proven track record for developing global CMC regulatory strategies in multiple markets simultaneously.
• An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
• Experience representing CMC regulatory affairs on regulatory and cross functional teams.
• Excellent written and verbal communication skills.
Required Years of Experience: At least 2 – 3 years of experience
Top 3 Required Skill Sets: Significant experience in CMC Regulatory Affairs; strong verbal and written communication skills; experience in leading and preparation of regulatory submissions
Top 3 Nice to Have Skill Sets: Experience with Veeva Vault, including RIM; global regulatory expertise
Unique Selling Point of this role: This role is a great opportunity to get experience in a CMC RA team, develop knowledge of Regulatory Affairs, and while working in data entry, may support the Team in other regulatory-related activities, such as supporting preparation of straight-forward submissions.
Job Location: Foster City, CA
Job Duration: 6 Months+ (Possible extension)
Pay range: $100/hr. on W2
Job Description:
• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. Ensure dossiers meet ICH and local regulatory requirements.
• Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the International markets.
• Liaise with colleagues in Regulatory Affairs therapeutics teams, Client local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
• Co-ordinate regulatory assessments for post-approval CMC changes, develop filing strategy and plans for assigned markets and execute filings according to agreed priorities.
• Maintain a current awareness of CMC registration requirements in each of the International regions and communicate key regulatory intelligence to the organization on a timely basis.
KNOWLEDGE, EXPERIENCE AND SKILLS
• BA/BS, MS or Ph.D or equivalent education.
• Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience.
• Experience in the preparation of CMC components of MAA or post-approval variation submissions for small molecule and/or biologics products.
• Biologics experience or drug-device combination product experience would be an advantage.
• A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
• Proven strategic thinking skills, with a proven track record for developing global CMC regulatory strategies in multiple markets simultaneously.
• An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
• Experience representing CMC regulatory affairs on regulatory and cross functional teams.
• Excellent written and verbal communication skills.
Required Years of Experience: At least 2 – 3 years of experience
Top 3 Required Skill Sets: Significant experience in CMC Regulatory Affairs; strong verbal and written communication skills; experience in leading and preparation of regulatory submissions
Top 3 Nice to Have Skill Sets: Experience with Veeva Vault, including RIM; global regulatory expertise
Unique Selling Point of this role: This role is a great opportunity to get experience in a CMC RA team, develop knowledge of Regulatory Affairs, and while working in data entry, may support the Team in other regulatory-related activities, such as supporting preparation of straight-forward submissions.
Source : Integrated Resources, Inc