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Regulatory Manager (GRAAS)

  • Job reference: 930558
  • Location: Uxbridge, London
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 20/03/2020

Orion Group Life Sciences have an exciting opportunity for a Regulatory Manager (GRAAS) for our Multinational Pharmaceutical client based in the Middlesex area on a 12-month contract.


Main Responsibilities of the role

Provide support as an individual contributor to ensure the execution of MRI team objectives:

  • Creation, submission and archiving of regulatory dossiers
  • Maintenance of regulatory document management systems and tracking systems
  • Maintenance of core dossier component structures
  • Quality control of regulatory dossiers, archive and tracking systems
  • Primary Regulatory Operations point of contact between TAs/CMC and publishing teams
  • Day-to-day issues management and workload balancing
  • Cross-TA information sharing and liaison with TAs/CMC for submission prioritization
  • Ensure timely data entry, administration of, and reporting from regulatory registration tracking system
  • Ensure timely submission of regulatory correspondence to the Regulatory Archive and maintenance of product history logs
  • Liaise with Global RDA teams and CMC system teams to ensure seamless and consistent approach to document management and maintenance of tracking systems
  • Ensure quality control procedures for dossiers, tracking system entries, regulatory archive locations and file naming conventions are in place and adhered to
  • Contribute to the development and roll out of training documentation and e-manuals
  • Electronic document management of ongoing submissions: collate dossier components into document management
  • Fill internal requests for information and documentation
  • Liaise with internal customers to determine key performance and compliance indicators
  • Liaise with reporting groups for Data Tracking System outputs
  • Maintain team Sharepoint sites and associated documentation
  • Represent Regulatory Operations on global workstreams for process improvements in document management and regulatory information tracking
  • Contribute to Information System enhancements and software update projects related to document management and regulatory information tracking
  • Develop standards and templates for routine reports
  • Create and maintain work request templates
  • Liaise with TAs/CMC and business partners to ensure timely document exchange

Desired Experience and Background of the successful candidate

  • Doctorate degree OR Master's degree & 3 years of directly related experience
    OR Bachelor's degree & 5 years of directly related experience
    OR Associate's degree & 10 years of directly related experience
    OR High school diploma / GED & 12 years of directly related experience
  • Previous experience leading projects, programs or directing the allocation of resources
  • Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations and Regulatory Guidance
  • Use of document management systems and databases
  • Good written and verbal communication skills
  • General understanding of industry practice and standards
  • Attention to detail
  • Relationship building
  • Time and project management skills
  • Organisational skills

#pharmaceutical #pharma #multinational #product #regulatoryaffairs

For more information on this role, call Kate O' Sullivan on +44 (0) 2039 944702 or email Kate.OSullivan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 930558


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.