About Us: PreClinIQ is a premier consultancy firm specializing in preclinical science services for the pharmaceutical and biotechnology industries. With a focus on innovation, integrity, and excellence, we offer comprehensive solutions to guide clients through the preclinical phase of drug development.
Job Description: We are seeking a talented and experienced Regulatory Specialist to join our team. The successful candidate will be responsible for providing expert regulatory guidance and support across various preclinical projects, facilitating the successful preparation and submission of regulatory documents leading up to the Investigational New Drug (IND) application.
Responsibilities:
- Develop regulatory strategies and roadmaps for navigating the preclinical development process, ensuring alignment with project goals and regulatory requirements.
- Provide regulatory guidance and support for preclinical study design, execution, and data interpretation, ensuring compliance with applicable regulations and guidelines (e.g., FDA, EMA).
- Prepare, review, and submit regulatory documents, including preclinical study protocols, reports, and IND applications.
- Interact with regulatory agencies, including participating in pre-IND meetings and responding to regulatory queries, to support successful IND submissions.
- Stay current with evolving regulatory requirements and industry trends, providing strategic insights and recommendations to project teams and clients.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline; advanced degree preferred.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on preclinical development.
- In-depth knowledge of regulatory requirements and guidelines governing preclinical studies and IND submissions (e.g., FDA regulations, ICH guidelines).
- Experience preparing and submitting regulatory documents for preclinical studies and IND applications.
- Strong communication skills, with the ability to effectively communicate regulatory requirements and strategies to internal teams and external stakeholders.
- Excellent organizational skills and attention to detail, with the ability to manage multiple projects and priorities in a fast-paced environment.
- Proven ability to work collaboratively in cross-functional teams and independently to drive project success.
Benefits:
- Competitive salary and benefits package
- Opportunities for professional development and career advancement
- Collaborative and supportive work environment
- Impactful work contributing to the advancement of drug development and healthcare innovation
How to Apply: Interested candidates are encouraged to submit their resume and a cover letter outlining their qualifications and interest.
PreClinIQ is an equal opportunity employer and welcomes applications from individuals of all backgrounds. We thank all applicants for their interest in joining our team, but only those selected for an interview will be contacted.
