- Oversee and maintain regulatory documents, including product dossiers, submissions, licenses, registrations, and approvals.
- Ensure adherence to regulatory requirements, standards, and guidelines pertinent to the industry and geographical areas of operation.
- Compile and organize documentation for regulatory submissions to health authorities, encompassing new product registrations, variations, renewals, and annual reports.
- Verify the quality, accuracy, and thoroughness of regulatory documentation through meticulous review, validation, and verification processes.
- Establish and manage document control protocols to govern version control, access, distribution, and archival of regulatory documents.
- Interface with internal stakeholders, regulatory agencies, and external collaborators to gather essential information, resolve inquiries, and facilitate the regulatory submission process.
- Stay abreast of regulatory changes, updates, and best practices to ensure compliance and proactively address regulatory complexities.
- Collaborate with interdisciplinary teams, including regulatory affairs, quality assurance, research and development, and manufacturing, to support regulatory initiatives and project schedules.
- Provide guidance and assistance to internal teams on regulatory documentation requisites, processes, and systems.
- Identify avenues for process enhancements, efficiency improvements, and automation in regulatory documentation management.
- Bachelor's degree in a relevant field such as life sciences, pharmacy, chemistry, or regulatory affairs. Advanced degrees or certifications may be advantageous.
- Demonstrated experience (typically 2-5 years) in regulatory affairs, regulatory documentation management, or related positions within regulated sectors.
- Thorough understanding of regulatory requirements, standards, and guidelines applicable to the industry, such as FDA regulations, ICH guidelines, and ISO standards.
- Strong attention to detail and organizational prowess to manage multiple projects, deadlines, and priorities efficiently.
- Excellent written and verbal communication abilities for crafting clear, concise, and precise regulatory documents and facilitating communication with stakeholders.
- Proficiency in document management systems, regulatory software tools, and Microsoft Office applications.
- Analytical acumen and problem-solving skills to decipher complex regulatory mandates, evaluate compliance challenges, and propose viable solutions.
- Capability to work autonomously with minimal supervision as well as collaboratively within a team setting.
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 'Employee's Choice - Best Places to Work' by Glassdoor.
- Voted 'Best Staffing Firm to Temp/Contract For' six times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine.
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Regulatory Documentation Specialist - Boston, United States - Digital Prospectors
Description
Position: Regulatory Documentation Specialist
Location: Boston, MA (Onsite)
Length: 6+ months
Job Description:
Our client is seeking a Regulatory Documentation Specialist who will be responsible for overseeing, organizing, and preparing regulatory documentation essential for product approvals, compliance, and submissions to regulatory authorities. The Regulatory Documentation Specialist will play a pivotal role in ensuring accuracy, completeness, and adherence to relevant regulations and guidelines.
Essential Duties and Responsibilities (but not limited to):
Qualifications:
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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