Regulatory Affairs Manager, Biopharma CMC – Remote Work (JP9338)
Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Regulatory Affairs Manager, Biopharma CMC – Remote Work (JP9338) Location: Thousand Oaks, CA. (Remote Work) Employment Type: Contract Business Unit:Regulatory Affairs - CMC Function Duration: 1+ years with likely extensions Posting Date: 10/22/2021
3 Key Consulting is hiring a Regulatory Affairs Manager for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: 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:
Assess minimum regulatory CMC requirements for post-approval programs
Provide regulatory strategy through development of MASP and/or event GIRS
Coordinate, develop and prepare CMC post-approval variations/ clinical CMC amendments
Maintenance of applications (Annual Reports, Annual Stability updates)
Maintain product compliance through appropriate regulatory filings and activities including regulatory commitments
Support Change Management activities, as needed
Support/lead responses to regulatory agency questions, as needed
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.
Why is the Position Open? Supplement additional workload on team
Top Must-Have Skill Sets:
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
Day to Day Responsibilities: See job description.
Basic Qualifications: Doctorate degree and 2+ years of directly related experienceOR Master’s degree and 3 years of directly related experienceOR Bachelor’s degree and 5 years of directly related experience
Employee Value Proposition: Strong oriented environment more exposure to biologics molecules.
No synthetics or small molecules CMC experience.
No lifecycle management experience.
No working knowledge of CTD.
Interview process: Video Skype Panel Interview
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.