Regulatory CMC Consultant
Position Overview
The Regulatory Consultant will support preparation of global regulatory submissions and contribute to regulatory CMC strategy and execution. This is a maternity leave backfill role requiring an experienced professional who can come in and contribute immediately with minimal onboarding time.
Key Responsibilities
Prepare documentation packages for global regulatory submissions including INDs, CTAs, Briefing Books, and Scientific Advice packages to FDA and global regulatory agencies Compile and review documentation for submissions to FDA and international regulatory agencies Support development of regulatory strategies, risk assessments, and issue identification in an evolving regulatory landscape Support development and improvement of regulatory submission processes and procedures Build and maintain collaborative partnerships with key internal and external stakeholders Participate in regulatory intelligence activities; monitor regulatory guidelines and trends and provide advice to project teams on applicability and impact to internal programs
Qualifications
BA/BS or higher in a scientific or engineering discipline 5 to 8 years of Regulatory CMC experience in biotech or pharma, or related experience in manufacturing, analytical, or quality assurance as a strong dossier preparation contributor for IND/CTA and BLA/MAA submissions Cell and gene therapy experience strongly preferred Comprehensive knowledge of FDA, EMA, and ICH guidelines with ability to apply regulatory CMC strategies for novel products Strong experience with CTD format and content regulatory filings Experience with diverse submission types including drugs, biologics, and international filings preferred Excellent organizational, written, and oral communication skills; ability to communicate complex issues clearly and concisely Strong interpersonal skills; collaborative, easy to work with, and responsive in a cross-functional team environment Ability to work independently, manage competing priorities, and exercise sound judgment
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The Regulatory Consultant will support preparation of global regulatory submissions and contribute to regulatory CMC strategy and execution. This is a maternity leave backfill role requiring an experienced professional who can come in and contribute immediately with minimal onboarding time.
Key Responsibilities
Prepare documentation packages for global regulatory submissions including INDs, CTAs, Briefing Books, and Scientific Advice packages to FDA and global regulatory agencies Compile and review documentation for submissions to FDA and international regulatory agencies Support development of regulatory strategies, risk assessments, and issue identification in an evolving regulatory landscape Support development and improvement of regulatory submission processes and procedures Build and maintain collaborative partnerships with key internal and external stakeholders Participate in regulatory intelligence activities; monitor regulatory guidelines and trends and provide advice to project teams on applicability and impact to internal programs
Qualifications
BA/BS or higher in a scientific or engineering discipline 5 to 8 years of Regulatory CMC experience in biotech or pharma, or related experience in manufacturing, analytical, or quality assurance as a strong dossier preparation contributor for IND/CTA and BLA/MAA submissions Cell and gene therapy experience strongly preferred Comprehensive knowledge of FDA, EMA, and ICH guidelines with ability to apply regulatory CMC strategies for novel products Strong experience with CTD format and content regulatory filings Experience with diverse submission types including drugs, biologics, and international filings preferred Excellent organizational, written, and oral communication skills; ability to communicate complex issues clearly and concisely Strong interpersonal skills; collaborative, easy to work with, and responsive in a cross-functional team environment Ability to work independently, manage competing priorities, and exercise sound judgment
Apply tot his job
Apply To this Job