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Regulatory Affairs Manager

Thousand Oaks, CA
Top 3 Must Have Skill Sets:    

Knowledge and Skills

CMC- regulatory knowledge & experience in small molecule (synthetics) products, specifically knowledge related to solid dosage form products (immediate and modified release)
CMC – regulatory knowledge in CMC amendments to clinical trial applications (IMPD/ IND)
Understanding and application of principles, regulatory guidance, and concepts, theories and standards of scientific/technical fields regarding solid dosage products

Description:

Remote
Please remember, will now require all staff, including field and remote staff, in the U.S. and Puerto Rico to be fully vaccinated against COVID-19 by November 1st. This means that, if you have not already been vaccinated, you should receive either a single-shot vaccine, or the second shot of a two-dose vaccine, no later than October 15th to account for the two-week period following the final dose to be fully vaccinated.

Job Details: Position is within Regulatory CMC organization.
Responsible for the strategy, preparation and execution of commercial and clinical CMC supplements, and registrations of small molecule (synthetics) products.
- Coordinate and manage product-specific tasks within the regulatory information system per the CMC Global product leads.
Interfaces with Global Regulatory Affairs, Regulatory Operations, International Regulatory CMC and other Global Reg CMC functions to coordinate the preparation of regulatory submissions, and in the identification of issues, risks and factors that may implicate a regulatory strategy or activity.
- Serve as Regulatory CMC liaison for the small molecule product team by providing the following services:
o Assess minimum regulatory CMC requirements for post-approval programs
o Provide regulatory strategy through development of MASP and/or event GIRS
o Coordinate, develop and prepare CMC post-approval variations/ clinical CMC amendments
o Maintenance of applications (Annual Reports, Annual Stability updates)
o Maintain product compliance through appropriate regulatory filings and activities including regulatory commitments
o Support Change Management activities, as needed
o Support/lead responses to regulatory agency questions, as needed
o Facilitate agency interactions, including meeting preparation, meetings, response trackers and briefing documents
- Liaise with development, operations, and commercial teams to ensure alignment of global regulatory strategies, timing, execution and plans
- Participate as an active member of cross-functional teams

Knowledge and Skills

CMC- regulatory knowledge & experience in small molecule (synthetics) products, specifically knowledge related to solid dosage form products (immediate and modified release)
CMC – regulatory knowledge in CMC amendments to clinical trial applications (IMPD/ IND)
Understanding and application of principles, regulatory guidance, and concepts, theories and standards of scientific/technical fields regarding solid dosage products

Education & Experience (Basic)

Doctorate degree and 2+ years of directly related experience
OR
Master’s degree and 3 years of directly related experience
OR
Bachelor’s degree and 5 years of directly related experience

"This posting is for Contingent Worker, not an FTE"
 

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