Regulatory Affairs Specialist at Genius Business Solutions Inc

Are you a passionate IT trailblazer – a growth focused, problem solver who takes full ownership of your work, wants to collaborate & co-create with fellow IT experts, innovate, learn new skills, create new solutions & drive your career to the pinnacle of your potential? If so, you will love working with our Sales Team – we are constantly innovating to create breakthrough solutions for our client’s growth through a vibrant, fun team culture. Read on below to learn more...

Featured in CNBC, Digital Journal, Fox News & CIO Review GBSI has been successfully serving the world’s top Fortune 500 organizations for the last 20+ years. GBSI IT teams and consultants have delivered more than 568 projects successfully within the automotive, manufacturing, retail & pharmaceutical domains across the world. Headquartered in Moline, IL GBSI’s clients and consultants are spread across the US, Canada, Europe & India. Join us to be a part of an ever growing, elite IT team & start building your dream career today!

To be a successful Regulatory Affairs Specialist you will embody GBSI's core employee characteristics of being passionate about IT, taking full ownership of your work & having a growth mindset. Additionally, you will exhibit strategic vision, thoughtful engagement, strong analytical/process skills, a bias for action, and the ability to partner with senior operational leaders.

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.

Preferred:

• Experience with cloud platforms (AWS, Azure) and related IAM services.
• Certification in IAM or security-related fields (e.g., CISSP, CISM) is a plus.

Location Preference:

• Basking Ridge, NJ

Apply today to join us as part of an elite IT team & let GBSI help you build the career of your dreams!

We are excited for your growth!

Equal Employment Opportunity Statement

GeniusBSI is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation.

All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.