What are the responsibilities and job description for the Senior Manager - CMC Regulatory position at TalentBurst, Inc.?
Position : Senior Manager - CMC Regulatory, Req# : 35627002
Location : San Rafael, CA (This role is Hybrid but candidates must be PST - West Coast California)
Duration : 12 Months Contract
Job Description :
Education and Experience :
A BA / BS degree in life sciences in chemistry, molecular biology, or similar is desirable. An advanced degree is a plus.
Key Responsibilities :
Planning, preparation and submission of global regulatory CMC-related content pertaining to clinical trial applications, marketing Application(s) and periodic reports for US and Ex-US markets in accordance with the developed regulatory strategy. Ensure that the sections are complete, well-written, and meet all relevant requirements.
Collaborating and staying aligned with Reg CMC Product Lead to assess change records of proposed manufacturing changes and provide strategic regulatory guidance for optimal implementation of changes.
Developing and reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.
Manage the timelines and deliverables to ensure submissions are aligned with program milestones.
Proactively identify issues and escalate.
Develop relationships with Regulatory Affairs, Manufacturing, Technical Development, Sites, and Quality to support submission preparation.
Provide regulatory advice to technical subject matter experts based on knowledge of current Quality (CMC) requirements.
Process documentation requests to support key application activities
Manage interactions with country regulatory authorities (FDA, EMA, HC, etc) for assigned projects relating to health authority queries.
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a Senior Manager - CMC Regulatory?
Sign up to receive alerts about other jobs on the Senior Manager - CMC Regulatory career path by checking the boxes next to the positions that interest you.
