Senior Manager - CMC Regulatory
Joulé
San Rafael, CA
Job Title: Senior Manager - CMC Regulatory
Location: Hybrid – Local to San Rafael, CA
Type: Contract
Description:
As a Senior Manager in the Regulatory CMC department this individual will be responsible/accountable for:
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.
Education:
- BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable. Advanced degree is a plus.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
About the Company
Joulé
Our Story
Impacting lives. It's in our DNA.
At Joulé, we believe our world is filled with possibilities – where character, integrity and commitment drive our purpose. For over 30 years, Joulé has been a trusted partner to industry leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent. Operating at the forefront of the life sciences arena, Joulé’s relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects. Joulé is a System One division.
Joulé consists of multiple business lines working together for client success: scientific, clinical, and healthcare recruiting plus equipment services.
Since our existence, we’ve excelled in these specialized markets, and in recent years we have further narrowed the Joulé brand to exclusively represent these arenas. Joulé's services are backed by the considerable reach and resources of our parent company, System One.
The Business of Science
Way back before STEM was a trend, Joulé established its roots in scientific and technical disciplines. We began life as an engineering services firm, but our business has evolved considerably to where it stands today:
- A leader in specialized workforce solutions and integrated services
- One of the top ten largest clinical and scientific staffing firms in the U.S.
- An ISO-certified provider of laboratory and facility support
- An advocate for scientific, clinical, and healthcare clients and candidates alike
National Reach with Local Expertise
Working at the intersection of business and science, we make it easier to recruit and deploy talent for ongoing work and on-demand projects in a host of disciplines. We’re still writing our story, but our future is built on a foundation of quality delivery and personalized service.