CMC Manager (Regulatory Affairs) - Remote / Telecommute
Cynet Systems
Remote
cmc
manager
regulatory
remote
telecommute
regulatory
cmc
management
compliance
assessment
lead
lifecycle
identification
March 16, 2023
Cynet Systems
Boston, Massachusetts
Job Description: Pay Range: $50hr - $58hr
Responsibilities:
Responsibilities:
- Well-versed in performing CMC compliance activities including Gap Analysis, CMC comparison, and validation for the quality reports.
- Experienced in the authoring assessment reports and Part2/ Expert reports for Dossiers.
- Experience in reviewing quality documents such as Reformulation studies, process validations, particle size method implementation and specification, stability indicating methods implementation, impurity
- Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle as needed for product in-license/due diligence review, product divestment, and product withdrawal.
- Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements, and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
- Planning the project by understanding the client's needs, managing project deliverables, and providing solutions in real time.
- Collaborate with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
- Manage execution/authoring of CMC documentation (Module 1, 2, and 3) for life cycle management - post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems.
- Knowledge of regulatory guidelines and relevant applications.
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
- Deliver all regulatory milestones for assigned products across the product lifecycle, Deliver on agreed SLAs with clients at contract and account/ project levels.
- Meet all monthly reporting/business metrics/KPIs requirements and manage internal control processes.
- Identify, communicate, and escalate potential regulatory issues/risks and propose mitigation.
- Ensure established policies and procedures of the organization/client are followed and ensure compliance.
- Demonstrate oral and written communication skills and the ability to communicate issues in a succinct and logical manner.
- Demonstrate ability to generate innovative solutions to problems and effectively collaborate with and communicate with key stakeholders.
- Demonstrate flexibility in responding to changing priorities, multi-tasking, and dealing with client expectations.
- Demonstrate effective leadership, communication, interpersonal skills, and soft skills.
- Bachelor's or masters degree required in science, engineering, or related field (advanced degree preferred).
- Proven and relevant regulatory affairs experience in the pharmaceutical, vaccine, or biological products; or related fields
- Marketing authorization experience.
- Proven Project Management experience.
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