Manager, Regulatory Affairs

🕒 2 days ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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📋 Description

• Manage advertising and promotional submissions (2253s) related to the BLA and serve as the Regulatory Affairs representative on the Promotional Review Committee. • Translate local, regional, and international regulatory requirements into workable plans with cross-functional teams. • Manage preparation, review, and submission of regulatory documents across non-clinical, clinical, and CMC modules for IND/CTA, BLA/MAA, and other global submissions. • Manage e-submission vendors as needed. • Collaborate with contributing authors across functional areas on submission content. • Ensure timely preparation of organized and scientifically valid applications. • Interact with regulatory agencies on defined matters. • Execute regulatory documentation infrastructure, including paper and electronic submissions. • Mentor, guide, and train direct reports. • Travel up to 15% as required.

🎯 Requirements

• Bachelor’s degree & 5+ years’ directly related experience. • Direct experience in promotional material review and knowledge of FDA OPDP requirements. • Minimum 5-7 years’ experience in pharmaceutical Regulatory Affairs with a focus on drugs/biologics. • Regulatory Affairs certification or equivalent training. • Experience in preparation, submission, and lifecycle management of investigational/marketing applications in eCTD format. • Knowledge of US, EU, Health Canada, Australia, and ICH regulatory requirements. • Experience directly interfacing with regulatory authorities. • Bachelor’s degree in Chemistry, Biology, Pharmaceutical Science or a related field is preferred.

🏖️ Benefits

• Competitive Compensation including base salary and annual performance bonus. • Flexible PTO, holidays, and parental leave. • Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

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