Regulatory Affairs Specialist

Company Description:

Position Overview:

Key Responsibilities:

• Regulatory Submissions:
• Prepare and review regulatory submissions in compliance with CMC eCTD/CTD requirements.
• Ensure timely and accurate submissions to regulatory authorities in the US UK EU and ROW markets.
• Regulatory Compliance:
• Monitor and interpret regulatory requirements and guidelines.
• Ensure compliance with all relevant regulatory standards and policies.
• Publishing and Submission:
• Expertly handle the publishing and submission of regulatory documents.
• Manage and maintain submission tracking systems.
• Regulatory Strategy:
• Develop and implement regulatory strategies to ensure successful registration and maintenance of products.
• Liaise with regulatory authorities and provide strategic guidance on regulatory matters.
• Crossfunctional Collaboration:
• Work closely with crossfunctional teams including R&D Quality Assurance and Clinical Development.
• Provide regulatory support and guidance throughout the product lifecycle.
• Documentation and Record Keeping:
• Maintain accurate and uptodate regulatory documentation and records.
• Prepare reports and documentation for internal and external audits.

Eligibility Criteria:

• Education:
• Bachelors or Master s degree in Life Sciences B Pharmacy or M Pharmacy.
• Experience:
• 48 years of experience in Regulatory Affairs specifically within the Healthcare Clinical Research Biotech Biopharma or Medical Device industries.
• Extensive experience with CMC eCTD/CTD requirements.
• Proven expertise in regulatory publishing and submission processes.
• Strong understanding of regulatory requirements in the US UK EU and ROW markets.

Skills and Abilities:

• Strong analytical and problemsolving skills.
• Excellent written and oral communication skills.
• Detailoriented with a strong focus on compliance and quality.
• Ability to manage multiple projects and deadlines.
• Proficiency in regulatory submission software and tools.

cmc,regulatory affairs,clinical development,publishing,regulatory submissions,documentation,row,compliance,clinical research