Position Overview:

We are seeking a detail-oriented and highly motivated Regulatory Submission Specialist to join our regulatory team. The Regulatory Submission Specialist will play a critical role in managing and overseeing the preparation, submission, and tracking of regulatory documents to global health authorities, including the FDA, EMA, and other regulatory bodies. This position offers the opportunity to work in a dynamic, fast-paced environment and contribute to the successful delivery of regulatory submissions for clinical trials and product approvals.

Key Responsibilities:

Regulatory Documentation Preparation:

Coordinate, compile, and prepare high-quality regulatory submissions including INDs, NDAs, BLAs, CTAs, MAAs, and amendments in compliance with regulatory requirements.
Ensure that all submission components (e.g., modules, reports, protocols) are accurate, complete, and prepared according to applicable guidelines and templates.

Submission Management:

Manage timelines and track progress of submissions to ensure timely delivery to regulatory authorities.
Serve as a point of contact with internal teams (clinical, medical writing, data management) and external partners (clients, regulatory authorities) to facilitate submission activities.

Regulatory Intelligence & Compliance:

Stay current with global regulatory requirements, guidelines, and best practices to ensure submission processes comply with local and international standards.
Support regulatory strategy discussions by providing insights on submission pathways and requirements for new products or clinical trials.

Quality Control:

Perform detailed quality checks of regulatory documents to ensure accuracy, completeness, and compliance.
Identify and resolve any inconsistencies or discrepancies in submission content or format.

Systems & Tools:

Use electronic submission systems (e.g., CTIS, IRAS, CESP) to prepare and submit regulatory dossiers.
Maintain regulatory tracking tools and databases to monitor submission status and compliance deadlines.

Required Qualifications:

Education: Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field. Advanced degree preferred.
Experience:

3-6 years of experience in regulatory submissions within the pharmaceutical, biotech, or CRO industry.
Strong knowledge of FDA, EMA, and other global regulatory requirements and submission formats (e.g., eCTD).

Technical Skills:

Proficiency in electronic submission platforms and regulatory document management systems.
Strong command of Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat.

Communication & Collaboration:

Excellent written and verbal communication skills.
Ability to work independently and collaboratively with cross-functional teams.

Attention to Detail:

High level of accuracy in reviewing and preparing complex regulatory documents.

Preferred Qualifications:

Familiarity with regulatory requirements for medical devices, biologics or NCEs.

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Senior Executive/Specialist - Regulatory Submission

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