Pharma Quest Private Limited jobs - Executive - Regulatory Affairs
Executive - Regulatory Affairs
Fresher
13,000 - 15,000 Per Month
Posted:
10 Months ago
Views:
Applications:
Openings:
1
Job Description
Executive - Regulatory Affairs
Fresher Mpharm/Bpharm ( preference Mpharm)
Communication Written : English
Speaking : English, Hindi, Telugu
Typing : Medium to High
Software Knowledge : MS office
You will be handling independent customer service with our clients
Responsibilities:
Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions.
Responsible for the preparation and review of quality regulatory submissions for various markets to ensure timely approval.
Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
Accountable for assessment, coordination and compilation of deficiency responses in a timely manner.
Works with other functional areas to resolve issues related to information for regulatory submissions.
Evaluate, prepare and review of post-approval supplements to manage the regulatory product life-cycle as applicable.
Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).
Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers and ensure accuracy of information.
Co-ordinate with third party manufacturers for document requirement for regulatory submissions.
Act as a back-up for team members and support as & when required.
Timely communication and follow-up with the respective departments for compilation and submissions and query responses to meet agreed timeline.
Interpret and ensure compliance with SOPs, RA policies & procedures and regulatory guidelines. Prepare and/or draft SOPs and regulatory guidelines (as applicable).
Interact with other applicable departments to discuss and provide solutions to regulatory issues and/or problems.
Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions.
Works in a safe manner collaborating as a team member to achieve all outcomes.
Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
All other relevant duties as assigned.
About Company
Pharma Quest Private limited is not marketing and Trading of Pharmaceuticals major business Export of API's
Jobs By LocationVIEW ALL
Others also searched for
Active Jobs By Role
Safety Tips
How to get a Job early? Follow these tips1.The more the Jobs you apply, the higher your chances of getting a job.
2. Keep your profile updated Update
Recruiters prefer candidates with complete profile information.
3. Keep visiting the Teamlease.com daily
Daily visit will ensure you won’t miss out on any Job opportunity.
4. Watch videos to improve Watch videos
Be a better candidate than others by watching these Job-related videos.
Jobs By Roles- Accountant |
- Architect |
- BPO / Telecaller |
- Tech Support |
- Content Writer |
- Fashion Designer |
- Data Entry |
- SEO / Social Media |
- HR / Admin |
- Engineer(Core,Non-IT) |
- Sales Executive |
- Management Trainee |
- Design / Animation |
- Teacher / Trainer |
- Delivery Executive |
- Chef / Cook |
- Counsellor |
- More Roles
Jobs By Cities- Ahmedabad |
- Bangalore |
- Chennai |
- Delhi |
- Hyderabad |
- Kolkata |
- Mumbai |
- Pune |
- Noida |
- Gurgaon |
- Chandigarh |
- Panaji |
- Patna |
- Bhopal |
- Ahmednagar |
- Bhubaneshwar |
- Pondicherry |
- Mohali |
- Jaipur |
- More Cities
Save & Update More
