Job Description
BioPharma Innovations is a leader in the development of next-generation therapeutics. We are currently seeking a Senior Regulatory Affairs Specialist to join our dynamic team in Boston, MA. In this pivotal role, you will drive the regulatory strategy for our clinical trials and product submissions, ensuring compliance with global health authority requirements. If you are a detail-oriented professional passionate about bringing life-saving medicines to market, we want to hear from you.
We offer a competitive salary, comprehensive benefits package, and a collaborative environment where your contributions directly impact patient outcomes.
Responsibilities
- Lead Regulatory Strategy: Oversee the preparation and submission of regulatory documents to the FDA, EMA, and other health authorities for clinical trials and product launches.
- Manage CMC Information: Direct the Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions, ensuring accuracy and compliance with ICH guidelines.
- Compliance Oversight: Monitor changes in global regulations and ensure our clinical development plans remain compliant with current Good Manufacturing Practices (cGMP).
- Stakeholder Liaison: Act as the primary point of contact with regulatory bodies, internal cross-functional teams, and external consultants.
- Database Management: Maintain and update the Regulatory Information Management System (RIMS) with the latest amendments and responses.
- Gap Analysis: Conduct thorough gap analyses to identify deficiencies in regulatory documentation and implement corrective actions.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Pharmacy, or related field required; Master’s degree preferred.
- Experience: Minimum of 5-7 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Technical Skills: Proficiency in eCTD software and strong knowledge of ICH-GCP and ICH M4 guidelines.
- Regulatory Knowledge: Demonstrated experience with FDA submissions (IND, NDA, BLA) and EMA procedures.
- Communication: Exceptional written and verbal communication skills, with the ability to explain complex regulatory concepts clearly.
- Problem Solving: Strong analytical skills with a proven track record of resolving regulatory inquiries efficiently.