Company
Our client is a leading organization in the pharmaceutical, chemical, and engineering sectors, dedicated to innovative product development and adherence to the highest safety and regulatory standards. The company values expertise, precision, and a collaborative approach to achieving scientific excellence.
Role Description:
The role involves providing essential regulatory support for Chemistry, Manufacturing, and Controls (CMC) filings related to various projects and products. The successful candidate will assist in coordinating and executing submission activities to ensure compliance with all regulatory requirements and project timelines.
Responsibilities:
- Support the preparation and submission of regulatory CMC documentation for assigned projects and products.
- Coordinate data collection, authoring, reviewing, and organizing CMC submissions.
- Respond to questions from health authorities or local subsidiaries, providing timely and accurate additional information to support filings.
- Follow regulatory guidelines and project plans under supervision, ensuring all activities are aligned with internal processes and timelines.
Requirements:
- Background in Chemistry, Pharmaceuticals, or Engineering.
- Strong understanding of regulatory processes and documentation.
- Proficiency in MS Office applications.
- Excellent coordination and communication skills.
- Ability to work effectively under direction and support team efforts.
Other Information:
If you are interested and want to apply, please submit your application via the apply button below and contact me.
57756
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.