Senior Manager, Regulatory Affairs III* - Leadstack Inc

LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.

Job Title: Senior Regulatory Affairs Manager CMC 
Duration: 6 months with the potential to extend
Location: Foster City, CA Hybrid
PR: $80/hr - $100/hr
 
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

Description:
RESPONSIBILITIES MAY INCLUDE

• 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, Gilead 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 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.
 
To know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/
Should you have any questions, feel free to call me on (415) 868-6741 /Sharif.khan@leadstackinc.com/
 

Sharif Khan

Senior Recruiter

 

C.	(415) 868-6741
A.	611 Gateway Blvd, Ste 120 South San Francisco, CA 94080
W.	www.leadstackinc.com