Regulatory Consultant/ Senior Consultant

Industry: Medical Foods, Drugs, Biologics, Cell Therapy, Gene Therapy, Combination Products, Antibody Drug Conjugates, Radiopharmaceuticals, Advanced Tissue Products, Medical Devices 

Employment Opportunity: 

CERES Regulatory Services is seeking a highly skilled and knowledgeable Regulatory Consulting Scientist to join our dynamic team. This role involves providing expert regulatory guidance and strategic support to clients across a broad spectrum of industries, including medical foods, drugs, biologics, cell therapy, gene therapy, combination products, antibody drug conjugates, radiopharmaceuticals, advanced tissue products, and medical devices. The ideal candidate will have a strong foundation in regulatory affairs, combined with a deep understanding of the scientific and technical aspects of product development and experience taking a product from concept to marketing application, to complete response or commercialization. The ideal candidate will bring a strategic approach to navigating regulatory challenges, supporting clients in achieving compliance and market success across a diverse range of indications and drug delivery technologies and routes of administration. 

Key Responsibilities: 

• Regulatory Strategy Development: Develop and implement comprehensive regulatory strategies that align with client objectives and comply with global regulatory requirements. 

• Submission Preparation and Review: Prepare and review regulatory submissions, including IND, BLA, NDA, and 510(k) applications, ensuring completeness, accuracy, and compliance. 
• Regulatory Intelligence and Compliance: Stay abreast of regulatory changes and trends across all relevant industries, advising clients on compliance strategies and regulatory risk management. 
• Client Consultation and Support: Provide expert consultation and support to clients on regulatory matters, including product classification, regulatory pathway selection, and pre-market and post-market requirements. 
• Cross-functional Collaboration: Work closely with cross-functional teams, including R&D, clinical affairs, quality assurance, and manufacturing, to ensure regulatory considerations are integrated throughout the product development lifecycle. 
• Certification in Regulatory Affairs (RAC) preferred. 

Technical Job Duties: 

• Conduct comprehensive regulatory assessments and gap analyses. 
• Develop and review quality systems and SOPs to ensure regulatory compliance. 
• Lead the preparation and submission of regulatory dossiers, applications, and documentation. 
• Coordinate and manage regulatory agency interactions, including meetings and correspondence. 
• Perform risk management activities related to regulatory strategy and compliance. 

Methodologies and Skills Required: 

• In-depth knowledge of regulatory frameworks and guidelines governing the development, approval, and post-market surveillance of products. 
• Scientific and Technical Expertise: Strong foundation in the scientific and technical aspects of product development, including clinical trial design, GMP, GCP, and GLP practices. 
• Skills in developing and implementing regulatory strategies that address both short-term objectives and long-term goals with an eye towards the least burdensome development program that will pass regulatory muster. 
• Experience in effectively engaging with regulatory authorities, industry stakeholders, and cross-functional teams. 
• Ability to critically evaluate regulatory challenges and develop innovative, compliant solutions. 

Required Qualities of the Candidate: 

• Analytical and Strategic Thinking: Ability to analyze complex regulatory requirements, approval pathways, regulatory programs design to accelerate development, and develop strategic approaches to compliance challenges and product approval. 
• Detail-Oriented: Exceptional attention to detail and the ability to manage multiple projects and priorities in a fast-paced environment experiencing rapid change. 

• Strong Communication Skills: Excellent verbal and written communication skills, with the ability to clearly articulate regulatory advice and present findings to clients and regulatory authorities. 
• Adaptability: Flexibility to adapt to changing regulations and guidelines across different industries, countries, and regions. 
• Collaborative Spirit: Ability to work effectively in a team and collaborate with clients and stakeholders from diverse backgrounds and nationalities. 

Qualifications Needed: 

• Master’s degree in Regulatory Affairs, Biotechnology, or a related field. 
• Minimum of 3-7 years of experience in regulatory affairs within the medical foods, drugs, biologics, cell therapy, gene therapy, combination products, or medical devices industries. 
• Proven track record of successful regulatory submissions and interactions with regulatory authorities. 
• Familiarity with global regulatory landscapes, including FDA, EMA, and other international regulatory bodies. 

Application Instructions: 

Please submit your resume, cover letter, and any relevant certifications or references that demonstrate your qualifications and experience in regulatory affairs and the specific medical product industries mentioned. In your cover letter, highlight your experience with regulatory submissions, strategic planning, and your ability to navigate complex regulatory landscapes and overcoming regulatory challenges.