Compliance Regulatory Expert
3 weeks ago
PSC Biotech invites applications for a Compliance Regulatory Expert position. As a critical member of our team, you will ensure that our healthcare products meet the highest standards, in compliance with all applicable regulatory requirements.
The successful candidate will receive a competitive $130,000 - $160,000 per year salary, plus benefits, and the opportunity to work remotely. In this role, you will be responsible for leading cross-functional teams, providing guidance and expertise, and ensuring compliance with regulatory requirements.
About the Role:
This is an exciting opportunity to join PSC Biotech's dedicated team and contribute to shaping the future of the pharmaceutical industry. You will be responsible for developing and implementing regulatory strategies for a range of drug products, including sterile injectables.
Responsibilities:
- Lead and manage regulatory projects from initiation to completion, ensuring timelines and milestones are met.
- Develop and implement regulatory strategies for a range of drug products, including sterile injectable products.
- Provide guidance and expertise to cross-functional teams during all stages of product development and regulatory requirements.
- Effectively track all project progress, evaluating and developing timelines, schedules, risks, and objectives.
- Proactively assess and communicate regulatory risks and opportunities.
- Conduct and assist in gap analysis.
- Prepare, review, and submit regulatory documents as needed.
- Ensure compliance with applicable regulations, guidelines, and industry standards.
- Monitor and interpret regulatory requirements and provide updates and guidance to team members and management.
- Serve as the primary contact with regulatory authorities and respond to inquiries and requests.
- Maintain accurate and complete regulatory documentation and project records.
- Ensure proper archiving of regulatory submissions and correspondence.
Requirements:
A Bachelor's or advanced degree in a related science discipline. Minimum 7+ years of experience in regulatory affairs within the pharmaceutical industry, with a focus on sterile injectables. Advanced knowledge of global regulatory requirements and guidelines.
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