Job Description

Role Summary
Position Title: RA Sr. Specialist - Variations Support
Location: Bangalore
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.
Key Responsibilities
• Review and provide regulatory impact assessments for changes
• Support 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
• Tracking of status, quality/compliance 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
• Excellent verbal and written English communication skills, suitable for multi-location working relationships
• Demonstrated teamwork and collaboration skills
• Aptitude for Attention to Detail

• Bachelor’s Degree or country equivalent in related scientific discipline
• Higher degree/PhD will be an advantage
Past Experience
• Minimum of 5 years’ regulatory experience in RA or related healthcare environment
• Higher degree/PhD will be an advantage