Reg Affairs Manager - Documentation

• -Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements
• Ensures compliance to the requirements from regulatory agencies
• Maintains the technical and non-technical documentation change system
• Assures procedures are in place to classify and maintain records
• Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements
• May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers
• May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched
• May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers

Your responsibilities include, but not limited to:

• Manages multiple, large and complex global regulatory submission projects.
• Develop and provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
• Contribute to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
• A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
• This job is the fully qualified, career-oriented, journey-level position .
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
• Contributes to many cost center goals and objectives; may contribute to service line goals -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)

• Minimum 10+ years of relevant experience
• Cross Cultural Experience.
• Managing Crises.
• Functional Breadth.
• Project Management.
• Collaborating across boundaries.
• Operations Management and Execution.

Skills:

• Data Analysis.
• Documentation Management.
• Lifesciences.
• Project Management.
• Regulatory Compliance.

Skills Desired