Sr Specialist - Regulatory Affairs
Baxter International · Bengaluru · onsite · Posted today
Undisclosed7–12 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Job Summary
Responsibilities
Qualifications
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
This is where your work makes a difference.
Your Role at Baxter: 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.
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
Qualifications
- Masters Degree or country equivalent in related scientific discipline
- Higher degree/PhD will be an advantage, 7+ years regulatory experience in RA or related healthcare environment
- Experience in Regulatory Information Management (RIM) systems, including managing regulatory data, submissions, registrations, and maintaining data quality and compliance.
- Experience in CMC regulatory authoring, including preparation and review of CTD Module 3 documentation and supporting global regulatory submissions throughout the product lifecycle.
- 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
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
data qualityEnglish CommunicationRegulatory AffairsBusiness RequirementsAuthoringChange Managementregulatory documentationregulatory knowledgeHealthcareRegulatory Information Managementoperationscompliance
About Baxter International
Baxter International
Healthcare
5k+
employees
1931
95 years old
Kolkata, West Bengal
India
₹20.4L PA avg
Avg at Baxter International
About
Baxter hires a range of talented and driven individuals with diverse skill sets and backgrounds, from scientists and researchers to industry professionals in manufacturing, engineering and technology,
Industries
HealthcareMedical EquipmentPharma
Employee ratings
10 reviews
3.8/ 5
Culture
3.9
Career growth
2.1
Work-life
3.5
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