Ambattur Chennai Tamil Nadu Affairs specialist Jobs – 5 Open Jobs Today

RA Specialist (US-FDA)
CellBios Healthcare And Lifesciences —Chennai, Tamil Nadu
- Email
- Microsoft Office
- Master's degree
- Analysis skills
RC-REGULATORY COMPLIANCE-Regulatory - BA-Senior
EY —Chennai, Tamil Nadu
- Computer Science
- Software troubleshooting
- Business development
14d
Service Lab Account Manager
Micro genomics India Pvt Ltd —Chennai, Tamil Nadu
- ₹30,000 - ₹60,000 a month
- Email
- Up to 50% travel
- Sales
- Laboratory experience
Quick apply
Service Lab Account Manager - Kochi - Hiring Sales Team
Medisequence Pvt Ltd —Chennai, Tamil Nadu
- Email
- Sales
- Master's degree
- Bachelor's degree
Quick apply
Service Lab Account Manager - Chennai - Hiring Sales
Medisequence Pvt Ltd —Chennai, Tamil Nadu
- Email
- Sales
- Laboratory experience
- Master's degree
Quick apply
1d

More jobs to discover

Find similar jobs that you might be interested in.

RC-REGULATORY COMPLIANCE-Regulatory - BA-Senior
EY —Chennai, Tamil Nadu
As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with…
14d

I want to receive the latest job alerts for affairs specialist in ambattur chennai tamil nadu

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

affairs specialist jobs near ambattur chennai tamil nadu

Account Manager jobs in Chennai, Tamil Nadu

Senior Compliance Officer jobs in Chennai, Tamil Nadu

Account Manager jobs in Thrissur R S, Thrissur, Kerala

Account Manager jobs in Lucknow, Uttar Pradesh

Account Manager jobs in Laxmi Nagar, Delhi, Delhi

Account Manager jobs in Bhosari, Pune, Maharashtra

Account Manager jobs in Palda, Indore, Madhya Pradesh

Relationship Manager jobs in Kolkata, West Bengal

Account Executive jobs in Remote

Marketing Manager jobs in Coimbatore, Tamil Nadu

Senior Resident, Pathology jobs in Delhi

Government Safety Officer jobs in Maharashtra

Senior Compliance Officer jobs in Hyderabad, Telangana

Senior Compliance Officer jobs in Bengaluru, Karnataka

Medical Officer, Insurance , Tpa Dentist , Bds jobs in Pune, Maharashtra

Senior Compliance Officer jobs in Noida, Uttar Pradesh

Senior Finance Manager jobs in Bengaluru, Karnataka

Account Manager jobs in Vasai, Maharashtra

Account Manager jobs in Mathura Road Faridabad, Faridabad, Haryana

Account Executive jobs in Thiruvananthapuram, Kerala

RA Specialist (US-FDA)

CellBios Healthcare And Lifesciences
Chennai, Tamil Nadu

Apply Now

Job details

Permanent

Qualifications

Microsoft Office
Master's degree
Analysis skills
Quality assurance
Product development
Data management
Quality control
Manufacturing
Document management systems
Communication skills
FDA regulations

Full job description

Job Location: Chennai

Role Description

This is a full-time on-site role for a Regulatory Specialist. The Regulatory Specialist will be responsible
for ensuring regulatory compliance, staying up-to-date with regulatory requirements, and utilizing
analytical skills to identify potential issues. The Regulatory Specialist will also be responsible for
communicating with regulatory agencies and providing regulatory affairs support to other teams.

Designation: RA Specialist (US-FDA)
Job Department: Regulatory Affairs
Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science
Regulatory Experience: Minimum 3 years in US FDA/ MDSAP/ 510 K submission
Industry/ Background – Medical Device /Pharma/Lifesciences Industry
Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm
Employment Status: Permanent
Job Location: Chennai
Workplace Type: On-site

Minimum Requirements:

Minimum of 2-3 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation.
Understanding of cGMP and US FDA guidelines.
Ability to effectively present information to management and other groups
Experience in preparing and managing regulatory dossiers, including DMFs, INDs, MAAs, and
other regulatory submissions.
Excellent understanding of pharmaceutical product development processes, manufacturing,
and quality control.
Strong attention to detail and accuracy in documentation and data management.
Effective communication and interpersonal skills, with the ability to collaborate with crossfunctional teams and interact with regulatory authorities.
Proficiency in using regulatory affairs software, document management systems, and
Microsoft Office Suite.
Ability to multitask, prioritize workload, and meet tight deadlines in a fast-paced and
dynamic environment.
Knowledge of international regulatory requirements and experience with Health Canada/
Brazil/ Japan/ USFDA/ Australia regulatory submissions is a plus.
Certification or training in USFDA/ Other Regulatory affairs is preferred

Roles and Responsibilities

The candidate will be responsible for handling and following of Regulatory process of USFDA
/ 510 K Submission.
Prepares eCTD filings for submission to the US Food and Drug Administration (US FDA) and
other global regulatory agencies.
Review and interpret regulatory guidelines and communicate updates and changes to
internal stakeholders.
Coordinate with cross-functional teams, including R&D quality assurance, and
manufacturing, to gather necessary information and documentation for dossier preparation.
Collaborate with regulatory authorities and agencies to address queries, provide additional
information, and facilitate dossier review processes.
Stay updated with evolving regulatory requirements and industry trends related to USFDA.
Assist in the preparation and submission of post-approval regulatory filings, variations, and
renewal applications.
Prepares all product listing, facility registration, product label updates, and facility
identification for submission to the US FDA.
Support and coordinate for MDSAP / ISO 13485 / QMS Audits, Internal Audits, and
Complaints and CAPA process.
Responsible for verifying specification of excipients, active, finished product and packaging
material, and all required documents.

Send your resume to: [email protected]

Apply Now

Refine Your Search

affairs specialist jobs in ambattur chennai tamil nadu

RA Specialist (US-FDA)

RC-REGULATORY COMPLIANCE-Regulatory - BA-Senior

Service Lab Account Manager

Service Lab Account Manager - Kochi - Hiring Sales Team

Service Lab Account Manager - Chennai - Hiring Sales

More jobs to discover

I want to receive the latest job alerts for affairs specialist in ambattur chennai tamil nadu

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected