Regulatory Support - Spark Life Solutions Inc
Basking Ridge, NJ 75074
About the Job
Roles & Responsibilities:
- Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance.
- Represents Regulatory Affairs on cross-functional project teams.
- Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents.
- Work with Veeva Submissions/Archive team, subject matter experts, and cross functional departments to support business needs.
- Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation.
- Gather and assemble information necessary for submissions in accordance with regulations/guidance.
- Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary.
- Conduct review of published submissions to ensure consistency and compliance with regulatory requirements.
- Maintain knowledge of local and global regulatory submission requirements.
- Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives.
- Provide Regulatory Affairs support during internal and external audits and inspections.
- Exposure in Change management process, requirement gathering, qualifying the changes etc.,
- Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc.
- Consistently support for regulatory systems access and change management.
- Responsible for communicating business process improvements, business related issues, status updates or opportunities.
- Bachelors' degree, preferably in a life science or a related field
- 5 to 10 years of experience in pharmaceutical environment.
- Experience in regulatory environment is required.
- Excellent written, verbal communication and presentation skills.
- High level exposure or knowledge about FDA inspection and internal audit process.
- Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc.
Source : Spark Life Solutions Inc
