Remote: Regulatory Generalist (234154)

Clinical Research & Clinical Affairs | Life Sciences & Technology


12+ Months

Job Description

Our client is seeking a Regulatory Generalist to support various functions related to international product renewals, manufacturing transfers to new facilities, and international regulatory filings. The client has tissue products that are classified differently across the globe based on local notified body requirements. As their product is improved and the manufacturing process is changed, those filings need to be updated and some require changes from Device filings to a BLA or from a tissue to a pharma product. This consultant will be fulfilling a variety of tasks including regulatory writing, submission work, coordinating operations for compliance and product release, and product renewals. There are deadlines for renewals in countries worldwide that will be the immediate need before moving into MAA, BLA filings, and Dossier filing. The ideal candidate will have 15+ years of regulatory experience including writing, international submissions, packaging/ad-promo compliance, and a strong blend of strategic/tactical capabilities.


  • Regulatory, international filings, EMA, Veeva RIM, BLA Filing, MAA, Device-Pharma-Biologic


  • Experience outweighs degree

Remote: Regulatory Generalist (234154)


About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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