Principal Regulatory Affairs Specialist Pharmaceutical Products Hybrid
Principal Regulatory Affairs Specialist Pharmaceutical Products Hybrid
Posted on :
18-04-2025
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1 Vacancy
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Job Description
Work Flexibility: Hybrid
We are currently seeking a Principal Regulatory Affairs Specialist Pharmaceutical Products to join our Medical Division. This is a Hybrid role based in Cary Illinois.
Who we want
As the Principal Regulatory Affairs Specialist you will play a pivotal role in shaping and executing global regulatory strategies for drug development and lifecycle management. This position requires extensive expertise in regulatory frameworks strategic planning and crossfunctional collaboration to ensure timely regulatory approvals and compliance with international standards. The individual will act as a senior advisor to internal teams providing regulatory guidance throughout all phases of drug development and commercialization.
- Regulatory Strategy Development
- Lead the development and implementation of comprehensive regulatory strategies for new drug applications (NDAs) OTC drug products including those marketed under the FDAs OTC monograph system investigational new (INDs) and postapproval submissions across global markets.
- Monitor and interpret evolving regulatory guidelines policies and industry trends to proactively adapt strategies.
- Provide strategic input on clinical trial designs product formulations and labeling to align with regulatory requirements.
- Submission Management
- Oversee the preparation review and submission of highquality regulatory dossiers including clinical trial applications (CTAs) INDs NDAs and variations.
- Ensure timely submission of documents in compliance with FDA EMA HC ICH and other international regulatory authorities.
- Manage responses to regulatory inquiries and negotiate directly with agencies to secure approvals.
- CrossFunctional Collaboration
- Serve as the primary regulatory representative on crossfunctional project teams involving R&D clinical development quality assurance manufacturing and marketing.
- Provide expert guidance on regulatory requirements during product development phases and postmarket activities.
- Collaborate with legal teams to ensure compliance with intellectual property laws and promotional regulations.
- Compliance & Risk Management
- Ensure adherence to current Good Manufacturing Practices (cGMP) Good Clinical Practices (GCP) Good Laboratory Practices (GLP) and other applicable quality standards.
- Assess the impact of product or process changes on existing approvals and coordinate necessary regulatory actions.
- Support audits and inspections by regulatory bodies; lead remediation efforts as required.
- Leadership & Mentorship
- Mentor junior regulatory staff members by sharing expertise in regulatory science and strategic planning.
- Develop internal training programs on regulatory updates and best practices.
- Contribute to the creation or revision of internal standard operating procedures (SOPs) related to regulatory affairs.
What you need
- Advanced degree in Pharmacy Life Sciences Chemistry or a related field Minimum of 10 years of experience in drug regulatory affairs.
- Experience interacting with regulatory agencies.
Preferred
- PhD PharmD or Masters
- RAC certification
- Masters in Regulatory Affairs
Required Experience:
Staff IC
Employment Type
Full-Time
Key Skills
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