Job Summary:

The Regulatory Affairs Specialist is responsible for ensuring that the company’s pharmaceutical products comply with all regulatory requirements set forth by the FDA and other relevant health authorities. This role involves preparing and submitting regulatory documents, maintaining up-to-date knowledge of regulatory guidelines, and collaborating with cross-functional teams to facilitate product development and commercialization.

Key Responsibilities:

1. Regulatory Submissions:

• Prepare and submit regulatory submissions to the FDA and other regulatory bodies, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Biologics License Applications (BLAs), and New Drug Submissions (NDS).
• Ensure all submissions are complete, accurate, and in compliance with regulatory requirements.

1. Regulatory Strategy and Planning:

• Develop and implement regulatory strategies to support product development and approval.
• Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, quality, and marketing.

1. Regulatory Research and Analysis:

• Stay current with FDA regulations, guidelines, and policies, as well as international regulatory requirements.
• Conduct regulatory research to identify changes in regulations and their potential impact on product development and commercialization.

1. Liaison and Communication:

• Act as the primary point of contact with regulatory agencies, including the FDA, and manage communications related to regulatory submissions and compliance.
• Coordinate with external consultants, contractors, and CROs to support regulatory activities.

1. Compliance and Documentation:

• Ensure that all regulatory activities and documentation are maintained in accordance with FDA regulations and company policies.
• Prepare and maintain regulatory files, including electronic submissions (eCTD) and documentation required for regulatory inspections and audits.

1. Project Management:

• Manage multiple regulatory projects simultaneously, ensuring timely and efficient submission of regulatory documents.
• Track and report on the status of regulatory submissions and provide updates to management and relevant stakeholders.

1. Quality and Continuous Improvement:

• Contribute to the development and implementation of quality systems and processes to enhance regulatory compliance and efficiency.
• Participate in internal and external audits, inspections, and meetings with regulatory agencies.

Qualifications:

• Bachelor’s degree in Pharmacy, Life Sciences, Biology, Chemistry, or a related field. Advanced degree preferred.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• Strong knowledge of FDA regulations, guidelines, and submission requirements.
• Experience with electronic submission systems (eCTD, eSubmitter).
• Excellent organizational, analytical, and problem-solving skills.
• Strong communication and interpersonal skills, with the ability to work effectively across departments and with external partners.

Preferred Qualifications:

• Certification in Regulatory Affairs (e.g., RAC).
• Experience with global regulatory submissions and international health authorities.
• Proven track record of successful regulatory submissions and product approvals.