Job Overview
We are looking for a dedicated and detail-oriented professional to join our team as a CMC Regulatory Affairs Data Entry Specialist. This position presents an exceptional opportunity for individuals who are committed to enhancing therapeutics for critical health conditions while collaborating within the Regulatory Affairs sector.
Key Responsibilities
- Execute data entry tasks utilizing our Regulatory Information Management (RIM) System to assist essential stakeholders in CMC Regulatory Affairs.
- Collaborate seamlessly with colleagues to carry out standard data entry activities, which include entering submission-related dates and providing regulatory assessment commentary.
- Ensure the precision, completeness, and consistency of all data input.
- Develop the necessary expertise and knowledge to effectively use our systems, receiving training and support from both your manager and peers.
- Work under the mentorship of experienced professionals in Regulatory Affairs CMC.
Required Skills
- Proficiency in data entry within complex information systems is crucial.
- Experience with Veeva Vault is mandatory, while familiarity with the RIM Vault is advantageous.
- Strong verbal and written communication abilities, alongside excellent interpersonal skills.
- Superior organizational skills with the ability to manage multiple projects simultaneously under strict deadlines.
- A foundational understanding of Regulatory Affairs and its requirements across various domains is important.
- A scientific background is preferred, particularly with experience in biologics.
Qualifications
- A minimum of 2-3 years of experience in a related field is required.
- A Bachelor's degree in a relevant discipline is preferred.
Career Growth Opportunities
This role offers a unique pathway for professional development within the dynamic field of Regulatory Affairs, enabling you to build expertise and advance your career.
Company Culture And Values
We pride ourselves on fostering a collaborative and innovative work environment, valuing diversity and inclusion, and encouraging all team members to contribute to our mission of advancing healthcare solutions.
Networking And Professional Opportunities
Joining our organization opens doors for networking and professional development, enhancing your skills and expanding your industry connections.
Employment Type: Full-Time
