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Syneos Health
Syneos Health
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Syneos Health este o organizație complet integrată de soluții biofarmaceutice, care ajută clienții să ducă terapiile de la dezvoltarea clinică până la furnizarea comercială. Echipele sale combină expertiza clinică, afacerile medicale, activitățile comerciale, tehnologia și informațiile despre piață pentru a răspunde nevoilor în schimbare din domeniul sănătății și pentru a sprijini dezvoltarea și lansarea unor tratamente importante în întreaga lume.
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Regulatory Manager, CMC Submissions — India Remote

Lead CMC submissions, lifecycle management, and global regulatory activities for Syneos Health’s life sciences services. Guide teams, clients, audits, and regulatory agency interactions.

INIndiaRemoteNormă întreagăSeniorLiderLimbă Obligatorie: englezăConformitate

Descriere

  • Assess existing product data against global and regional regulatory requirements
  • Develop gap analyses, product development plans, and regulatory submissions
  • Compile administrative and technical submission components for INDs, pre-approval packages, product registrations, and post-approval maintenance
  • Develop briefing packages for regulatory agency meetings and scientific advice
  • Contribute to regulatory agency communications and interactions
  • Manage daily regulatory activities according to timelines, scope, budgets, and project strategies
  • Provide regulatory guidance to multidisciplinary product development teams across the product lifecycle
  • Serve as a subject matter expert and resolve project-related issues
  • Develop regulatory service estimates for proposals
  • Support client discussions on proposals, project progress, and business development
  • Maintain compliance with global regulatory requirements, company policies, and established processes
  • Create training materials and communicate regulatory best practices internally and externally
  • Take part in internal and external project audits
  • Contribute to internal cross-functional initiatives
  • Develop and maintain SOPs and process documentation
  • Provide oversight for team members delivering project responsibilities
  • Recognize when additional line support is required
  • Keep individual training records current and complete assigned training

Cerințe

  • At least 10 years of regulatory affairs experience
  • Experience as a functional lead with team leadership responsibility
  • Capability in risk assessment, strategic planning, decision-making, and project leadership
  • Experience managing internal and external stakeholders
  • M. Pharm degree
  • Experience with CMC Module 3
  • Experience authoring CMC sections for post-approval variations and lifecycle management activities
  • Experience with EU and GCC markets
  • Master’s degree, preferably in a science discipline, or equivalent experience in science, regulatory, or medical writing
  • Moderate experience in pharmaceutical or medical device environments
  • Experience contributing to IND, PMA, NDA, MAA, and CTD regulatory submissions, including electronic submissions
  • Strong written and verbal communication skills
  • Strong customer service skills and the ability to work independently and collaboratively
  • Good quality management skills
  • Advanced proficiency with Microsoft Office
  • Ability to work with colleagues across departments and offices to establish project standards
  • Initiative, adaptability, and a proactive approach
  • Strong analytical ability and attention to detail
  • Ability to manage multiple concurrent projects with varying instructions
  • Fluency in spoken and written English, including reading comprehension

Beneficii

  • Opportunities for career growth and progression
  • Supportive, engaged line management
  • Training in technical and therapeutic areas
  • Peer recognition programs
  • Total rewards program
  • Inclusive workplace culture
  • Reasonable accommodations where appropriate

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