Regulatory Affairs Associate III - Katalyst CRO : Job Details

Join to apply for the Regulatory Affairs Associate III role at Katalyst CRO

Join to apply for the Regulatory Affairs Associate III role at Katalyst CRO

• Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations.
• Plans and organizes registration packages for device products.
• Prepares registration packages in line with local regulatory requirements and guidelines.
• With oversight, understand and respond to regulatory agency correspondence.
• Evaluates manufacturing and labelling changes for regulatory impact.
• Accurately describes these changes for ease of regulatory agency review.
• Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations.
• Accurately describes these changes for ease of regulatory agency review.
• Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions.
• May serve as a lead regulatory representative to an assigned product or project team.
• Review and approve critical documents, seeking guidance when necessary.
• Review technical reports and determine acceptability for regulatory submission.
• Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
• Understand global regulations and assure regulatory compliance, minimizing development costs and cycles.
• Prepare and maintain regulatory strategy with supervision.
• Exercise good judgment within policy and regulations.
• Responsible for tracking and completion of assigned registration activities.
• Accountable for accuracy of work and meeting multiple, simultaneous deadlines.
• Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.
• Follows scientific arguments, identifies regulatory scientific data needs and regulatory issues with alignment of regulatory management.
• Presents scientific data effectively orally and in writing in a logical and persuasive manner.
• Provides daily regulatory support to new product development teams and commercial support with guidance.
• Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.
• Acts with minimal oversight on routine issues, makes judgment and executes in alignment with regulatory management.

Responsibilities

• Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations.
• Plans and organizes registration packages for device products.
• Prepares registration packages in line with local regulatory requirements and guidelines.
• With oversight, understand and respond to regulatory agency correspondence.
• Evaluates manufacturing and labelling changes for regulatory impact.
• Accurately describes these changes for ease of regulatory agency review.
• Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations.
• Accurately describes these changes for ease of regulatory agency review.
• Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions.
• May serve as a lead regulatory representative to an assigned product or project team.
• Review and approve critical documents, seeking guidance when necessary.
• Review technical reports and determine acceptability for regulatory submission.
• Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
• Understand global regulations and assure regulatory compliance, minimizing development costs and cycles.
• Prepare and maintain regulatory strategy with supervision.
• Exercise good judgment within policy and regulations.
• Responsible for tracking and completion of assigned registration activities.
• Accountable for accuracy of work and meeting multiple, simultaneous deadlines.
• Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.
• Follows scientific arguments, identifies regulatory scientific data needs and regulatory issues with alignment of regulatory management.
• Presents scientific data effectively orally and in writing in a logical and persuasive manner.
• Provides daily regulatory support to new product development teams and commercial support with guidance.
• Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.
• Acts with minimal oversight on routine issues, makes judgment and executes in alignment with regulatory management.

Requirements:

• Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• RAC Certification is preferred.
• A minimum of 2 years of experience in the Medical Products Industry in Regulatory Affairs.
• Able to assess scientific arguments and apply analytical and logical reasonings.
• Ability to effectively prioritize workload and multitask with minimal supervision.
• Good interpersonal skills.
• Good oral and written communications skills.
• Demonstrated project management skills.
• Demonstrated critical thinking, contingency planning and negotiating skills.
• Understanding of regulatory and business needs with ability to engage cross functional team members.

Seniority level

• Seniority levelEntry level

Employment type

• Employment typeContract

Job function

• Job functionLegal
• IndustriesPharmaceutical Manufacturing

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