Position Title: Regulatory & Compliance Support Consultant
Location: Basking Ridge, NJ (Mostly Remote)
- This role has a Remote option, however, MUST be Local in the Area
- Requires Onsite for at least 2 - 4 days per month (Can Fluctuate, but average of two days a month)
- Must provide proof of local area location
Interview Mode: MS Teams Video Call
Approximate Duration: 12+ month contract
Mandatory skills:
- Experience in pharmaceutical environment.
- Experience in regulatory environment is required.
- High level exposure or knowledge about FDA inspection and internal audit process.
- Experience on Veeva RIM Submission/Archive, Publishing etc.
JD details :
- 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.
Qualifications:
- 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.
