Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Post : Associate, RA Variations Support
Job Purpose
This role is responsible for providing regulatory support for on-market products. Activities include change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams.
This role is responsible for providing regulatory support for on-market products. Activities include change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams.
Key Responsibilities
• Review and provide regulatory impact assessments for changes
• Manage global submission deliverables for product variation submissions
• Responsible for working with other parts of the regulatory organization to achieve desired results.
• Execute global plans and regulatory submission deliverables for sustaining variations
• Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results
• Ensure identified standards and content requirements are met for regulatory submissions
• Timely, actively support query responses
• Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements
• Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).
• Maintain regulatory files in a format consistent with requirements
• Track of status and progress of regulatory documentation
• Review, edit and proofread regulatory documentation
• Review and provide regulatory impact assessments for changes
• Manage global submission deliverables for product variation submissions
• Responsible for working with other parts of the regulatory organization to achieve desired results.
• Execute global plans and regulatory submission deliverables for sustaining variations
• Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results
• Ensure identified standards and content requirements are met for regulatory submissions
• Timely, actively support query responses
• Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements
• Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).
• Maintain regulatory files in a format consistent with requirements
• Track of status and progress of regulatory documentation
• Review, edit and proofread regulatory documentation
Key skills and competencies
• Experience operating in a regulated environment
• Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines
• Exercise independent judgement
• Scientific knowledge and ability to discuss technical matters with cross-functional team members
• Knowledge of regulations and ability to communicate and apply
• Ability to identify compliance risks and escalate when necessary
• Experience operating in a regulated environment
• Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines
• Exercise independent judgement
• Scientific knowledge and ability to discuss technical matters with cross-functional team members
• Knowledge of regulations and ability to communicate and apply
• Ability to identify compliance risks and escalate when necessary
Candidate Profile
• Bachelor’s Degree or country equivalent in related scientific discipline
• Higher degree/PhD will be an advantage
• RA experience
• Manager - Minimum of 7 years’ regulatory experience in RA or related fields
• Specialist - Minimum of 5 years’ regulatory experience in RA or related fields
• Sr. Associate - Minimum of 2 years’ regulatory experience in RA or related fields
• Associate – No regulatory experience required.
• Higher degree/PhD will be an advantage.
• Experience in an healthcare environment required
• Bachelor’s Degree or country equivalent in related scientific discipline
• Higher degree/PhD will be an advantage
• RA experience
• Manager - Minimum of 7 years’ regulatory experience in RA or related fields
• Specialist - Minimum of 5 years’ regulatory experience in RA or related fields
• Sr. Associate - Minimum of 2 years’ regulatory experience in RA or related fields
• Associate – No regulatory experience required.
• Higher degree/PhD will be an advantage.
• Experience in an healthcare environment required
Additional Information
Experience : 2 - 7 years
Qualification : B.Sc, Ph.D
Location : Bangalore, KA
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 10th January, 2019
Experience : 2 - 7 years
Qualification : B.Sc, Ph.D
Location : Bangalore, KA
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 10th January, 2019
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