Regulatory Affairs Manager

November 8

Apply Now

Receive Emails with Similar Jobs

BioMarin Pharmaceutical Inc.

WebsiteLinkedInAll Job Openings

Biotechnology • Pharmaceuticals

BioMarin Pharmaceutical Inc. is a leading global biotechnology company dedicated to transforming genetic discoveries into innovative medicines. Founded in 1997, the company has developed eight marketed products that address life-threatening genetic and lysosomal storage disorders such as achondroplasia and severe hemophilia A. BioMarin is also heavily invested in research and development, with a robust pipeline of investigational medicines at various clinical trial stages. The company's mission revolves around improving patient care by leveraging scientific expertise to understand the underlying causes of these conditions. BioMarin is committed to inclusivity and patient advocacy, engaging closely with communities to enhance care and quality of life for those with rare conditions.

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2020-05

📋 Description

• Support the development of the nonclinical / clinical regulatory strategy and plan. • Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions. • Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead. • Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials. • With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions. • Responsible for ensuring high quality nonclinical/clinical content that adheres to regulations and guidances. • Lead the maintenance of IND/CTAs throughout the life of the studies (e.g., annual reports) • Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review. • Collaborate with Reg PM to create and align submission timelines, • Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA. • Oversee the collaboration of Nonclin/clin with Reg Ops to provide final documents and QC published outputs for submissions to HA. • Organize and maintain the administrative, nonclinical, and clinical portions of IND’s, NDA’s and BLA’s. • Oversee the archiving of HA submissions and correspondence. • Provide support to RNC lead on development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions, examples are: clinical or nonclinical supplements to approved US product dossiers and any required annual reports, license renewals, supplemental filings. • Coordinate necessary interactions with INTL in support of INTL MA filings. Examples include: meetings to provide RNC guidance/input on agency interaction, submissions, RTQs. • Attend relevant functional area and project team meetings. • Review, understand and stay up to date on regulations, guidelines relevant to responsibilities • Review documents (SOPs, protocols and reports) related to Clinical or Nonclinical studies as necessary • Ensure that the PM timelines and tracker accurately reflect submission plans

🎯 Requirements

• Degree in health or life sciences, including chemistry, molecular biology, or similar. • PhD preferred, Masters/Bachelors acceptable with relevant experience • 4 + year experience • Nonclinical / Clinical Regulatory Affairs experience preferred

🏖️ Benefits

• Equal Opportunity Employer/Veterans/Disabled