What are the responsibilities and job description for the Regulatory Affairs Manager position at Randstad Life Sciences US?
Senior Manager - CMC Regulatory
1 Year (Extendable)
San Rafael, CA
Max PR : $70-80 / hr
This role is Hybrid but candidates must be PST - West Coast California
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.
QUALIFICATIONS
Required
Salary : $70 - $80
