Scientist, Regulatory Affairs

Position Overview

We are seeking a highly skilled and detail-oriented Regulatory Scientist to join our regulatory team. This role is crucial in the preparation, submission, and management of Investigational New Drug (IND) applications and New Drug Applications (NDA) to the FDA. The ideal candidate will have a strong understanding of regulatory requirements, excellent project management skills, and the ability to collaborate effectively with clinical development, quality assurance, and CMC teams.

Key Responsibilities

Regulatory Strategy Development:

1. Develop and implement regulatory strategies and health authority engagement plans for drug development.
2. Provide regulatory guidance throughout the drug development lifecycle, from preclinical to post-marketing.
3. Assess regulatory risks and develop mitigation strategies to support program success.

IND/NDA Preparation and Submission:

1. Lead the preparation and submission of IND and NDA applications, ensuring compliance with FDA requirements and adherence to submission timelines.
2. Work closely with clinical, non-clinical, and CMC teams to compile regulatory documentation, including clinical study reports, pharmacology, toxicology, and CMC data.
3. Establish and maintain submission timelines, ensuring alignment with regulatory and project milestones.

Regulatory Compliance and Monitoring:

1. Stay current with FDA regulations, guidance documents, and industry standards to ensure compliance and inform strategic decisions.
2. Monitor changes in regulatory requirements and assess their impact on ongoing and future projects.

Liaison with Regulatory Agencies:

1. Serve as the primary contact for the FDA and other regulatory agencies during the IND/NDA submission process.
2. Prepare for and participate in regulatory meetings, including pre-IND and pre-NDA meetings.
3. Address agency inquiries and coordinate responses to requests for additional information.

Cross-Functional Collaboration:

1. Work closely with clinical, non-clinical, CMC, and quality assurance teams to ensure regulatory compliance across all aspects of drug development.
2. Facilitate cross-functional communication to ensure timely and accurate submission of required data and documentation.

Post-Submission Activities:

1. Support post-submission activities, including responding to FDA queries, preparing for advisory committee meetings, and managing labeling and promotional materials.
2. Assist in the preparation of annual reports and other regulatory filings as required.

Qualifications

Education:

1. Master’s degree in life sciences, pharmacy, or a related field (Ph.D. preferred).

Experience:

1. Minimum of 5 years of experience in regulatory affairs.
2. Proven track record of successful FDA submissions and regulatory agency interactions.

Knowledge and Skills:

1. Deep understanding of FDA regulations, guidance documents, and the drug development process.
2. Strong analytical skills with the ability to interpret complex regulatory requirements.
3. Excellent written and verbal communication skills for effective engagement with cross-functional teams and regulatory agencies.
4. Strong project management abilities, capable of handling multiple projects and deadlines in a fast-paced environment.
5. Proficiency in Microsoft Office Suite and regulatory submission software.

Personal Attributes:

1. Highly detail-oriented with a commitment to quality and regulatory compliance.
2. Ability to work independently while also being an effective team player.
3. Strong problem-solving skills with a proactive approach to challenges.

Interested candidates please send your information to hr@sanegenebio.com.