Prepare for Your Bayer Zydus Pharma Interview with Real Experiences!
View interviews
AmbitionBox
Search
Jobs
- Reviews
- Salaries
- Interview Questions
- About Company
- Benefits
- Jobs
- Office Photos
- Community
Add office photos
All Filters
156 Bayer Zydus Pharma Jobs
Manager Regulatory Affairs, Medical Dev
Bayer Zydus Pharma
posted 3+ weeks ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Position Purpose:
The Regulatory Affairs Manager Medical Devices will be responsible for managing the regulatory strategy and ensuring the compliance of radiology medical devices with applicable regulations. This role involves working closely with internal teams, including global regulatory affairs, commercial, supply chain, quality assurance, legal, etc. to navigate the regulatory approval process for medical devices . The manager will monitor regulatory changes, support product submissions, and ensure timely approvals to maintain product marketability in India and some other South Asia markets. Additionally, the role will involve managing interactions with regulatory agencies, maintaining product documentation, and ensuring ongoing compliance with relevant standards and guidelines.
YOUR TASKS AND RESPONSIBILITIES
- With the support from Global Device Regulatory Affairs teams, prepare the submission dossiers for India import license applications for Bayer Radiology medical devices.
- Provide regulatory responses to local health authorities as required in a timely, proactive, systematic, accurate manner, to ensure timely approval new licenses and proper maintenance for existing licenses.
- Provide device regulatory assessments (e.g. product development, life-cycle engineering changes, etc.) for India as per required timelines to the G lobal Regulatory Affairs teams.
- Review the device labelling materials to ensure the compliance to local labelling requirements.
- Monitor and communicate the new or updated regulations from India, as well as supporting the impact assessment and implementation strategy as needed; and ensure that the device regulatory requirements of India are kept up to date in database systems.
- Support the policy research and shaping activities as required for the India device business.
- Develop and maintain tracking of regulatory device activities, including submission prioritization, submission status tracking and submission dossiers archiving.
- Support Commercial, Supply Chain, Order to Cash, Legal, Quality and/or Services by providing requested information and advices from India regulatory standpoint.
- Work in close collaboration, ensuring alignment and effective communication with APAC Device Regulatory Head, India Commercial and Global Device Regulatory Affairs teams.
WHO YOU ARE:
- PhD / Masters / Graduate in Engineering, Pharmaceutical, Chemistry or Biological Sciences.
- 3-5 years of proven India regulatory experience in pharmaceutical or medical device industry, including hands on India registration experience and direct working experience with CDSCO.
- Familiar with local regulations and regulatory assessment of design changes.
- Experience multitasking in a deadline controlled and highly regulated environment.
- Proven ability to communicate effectively in English both verbally and in writing.
- Skill and determination to reach successful outcomes in negotiations with both inside team clients and outside parties e.g., CDSCO.
- Detail oriented and well-organized.
- Motivated to work independently as well as with cross-functional teams.
Employment Type: Full Time, Permanent
Read full job description
What people at Bayer Zydus Pharma are saying
What Bayer Zydus Pharma employees are saying about work life
based on 140 employees
Flexible timing
Monday to Saturday
Within city
Day Shift
Bayer Zydus Pharma Benefits
View more benefits
Compare Bayer Zydus Pharma with
Astral Adhesives
Compare
Chemplast Sanmar
Compare
Henkel Adhesives Technologies
Compare
Pon Pure Chemical
Compare
Fosroc India
Compare
Epsilon Carbon
Compare
Indigo Paints
Compare
Zydex Industries
Compare
LANXESS India Private Limited
Compare
Sakata Inx
Compare
Siegwerk
Compare
Huntsman International
Compare
Matix Fertilisers & Chemicals
Compare
Colourtex
Compare
Parijat Industries (India)
Compare
Gulbrandsen
Compare
Rubamin
Compare
Jesons Industries
Compare
Neogen Chemicals
Compare
Clean Science And Technology
Compare
Similar Jobs for you
Manager Regulatory Affairs, Medical Dev
3-5 Yrs
New Delhi
Pharmacy, Regulatory Affairs, Supply Chain +3 more
Sr Medical Advisor - Oncology
2-6 Yrs
Mumbai
Pharmacovigilance, Clinical Research, Market Research +5 more
Associate - Invoice Processing GS
1-2 Yrs
Bangalore / Bengaluru
Data Entry, Architecting, Management +6 more
Medical Science Liaison
0-3 Yrs
Mumbai
Networking, Recruitment, Advertising +6 more
Business Officer
2-3 Yrs
Kottayam
Healthcare, Recruitment, Advertising +7 more
Executive Sales & Administration
2-7 Yrs
Thane
Sales, MIS, Recruitment +4 more
Process Lead - Invoice Processing
2-7 Yrs
Bangalore / Bengaluru
SAP, Auditing, Procurement +6 more
Manager FA Local Reporting & GL
4-5 Yrs
Thane
Auditing, MS Office, Monitoring +6 more
Subject Matter Expert - GL
6-11 Yrs
Bangalore / Bengaluru
Financial Analysis, Operations, Auditing +7 more
Share an Interview