Mumbai Maharashtra Regulatory affairs chemical Jobs – 3 Open Jobs Today

Regulatory Affairs Manager
Real Stock Analyzer —Mumbai, Maharashtra
- ₹8,00,000 - ₹12,00,000 a year
- Full-time
- Research
- Bachelor's degree
- Accounting
- Health insurance
- Life insurance
Quick apply
Regulatory Affairs – Chief Manager
Exeltis India —Mumbai, Maharashtra
- Email
- Master's degree
- Bachelor's degree
- APIs
DGM - Biologics External Manufacturing & Supply Operations
Sun Pharmaceutical Industries Ltd —Mumbai, Maharashtra
- Doctoral degree
- Master's degree
- Project management
1d

More jobs to discover

Find similar jobs that you might be interested in.

Regulatory Affairs – Chief Manager
Exeltis India —Mumbai, Maharashtra
Organise the regulatory submission schedule and coordinate with global Regulatory Affairs teams to align Indian filings with international timelines.
Senior Counsel, India
Mondelēz International —Mumbai, Maharashtra
To support commercial and corporate initiatives, you identify business needs and design and implement our legal strategy through the service delivery model.

I want to receive the latest job alerts for regulatory affairs chemical in mumbai maharashtra

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

regulatory affairs chemical jobs near mumbai maharashtra

Regulatory Affairs Manager jobs in Mumbai, Maharashtra

Operations Associate jobs in Mumbai, Maharashtra

Real Estate Closing Manager jobs in Kharghar, Navi Mumbai, Maharashtra

Regulatory Affairs Manager jobs in Tamil Nadu

F&b Manager jobs in Pune, Maharashtra

Admission Manager jobs in Bengaluru, Karnataka

Operations Associate jobs in Visakhapatnam, Andhra Pradesh

Claims Associate jobs in Bengaluru, Karnataka

Operations, Back Office, Office Executive jobs in Bilaspur, Chhattisgarh

Operations Associate jobs in Andheri, Mumbai, Maharashtra

Associate Dentist jobs in Mumbai, Maharashtra

Operations Associate jobs in Remote India

Operations Associate jobs in Kolkatta G.p.o., Kolkata, West Bengal

Customer Success Associate jobs in Bengaluru, Karnataka

Manager, Purchase ,billing jobs in Haridwar, Uttarakhand

Regulatory Affairs Manager jobs in Gujarat

Regulatory Affairs Manager

Real Stock Analyzer
Mumbai, Maharashtra

Quick apply

Job details

Permanent | Full-time
₹8,00,000 - ₹12,00,000 a year

Benefits

Provident Fund
Health insurance
Life insurance

Qualifications

Research
Bachelor's degree
Accounting
APIs
Time & attendance systems

Full job description

Job Summary:
We are seeking a highly skilled Regulatory Affairs – Assistant Manager (Europe Market) to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes.

Essential Duties and Responsibilities:

Technical Expertise

Proven experience in preparing CEPs/ASMFs from scratch.
Experience in submitting and maintaining ASMFs/DMFs and CEPs (initial submissions and variations) to the EDQM and/or European National Competent Authorities.

Regulatory Compliance

Ensure company products comply with relevant regulatory requirements and local regulations.

Software Knowledge

Familiarity with electronic submission systems and validation software such as Pharmaready and Lorenz.

Document Preparation

Proven ability to independently prepare Modules I, II, and III for APIs and Excipients.

Login/Account Creation

Knowledge of creating company logins/accounts on various country regulatory portals.

Regulatory Strategy

Develop and implement regulatory strategies to support product development and commercialization.

Regulatory Intelligence

Stay up to date with changing regulatory requirements and provide guidance to internal stakeholders.

Audits and Inspections

Coordinate and manage regulatory audits and inspections.

Regulatory Agency Interactions

Communicate with regulatory agencies such as the European Medicines Agency, European Directorate for the Quality of Medicines & HealthCare, and U.S. Food and Drug Administration to address questions and concerns.

Regulatory Documentation

Maintain and manage regulatory documents, including submissions, approvals, and correspondence.

Training and Guidance

Provide regulatory training and guidance to internal stakeholders.

Compliance Monitoring

Monitor company activities to ensure compliance with regulatory requirements.

Additional Advantage

Experience in preparing and submitting DMFs, Master Files, and regulatory submissions for regions including:
United Kingdom
Australia
Brazil
GCC
Jordan
Switzerland
Ukraine
Tunisia
Singapore
Mexico

Skills:

Strong knowledge of regulatory submissions and dossier preparation.
Strong knowledge of regulatory research and compliance requirements.
Familiarity with chemical industry-specific regulations and guidelines.

Pay: ₹800,000.00 - ₹1,200,000.00 per year

Benefits:

Health insurance
Life insurance
Provident Fund

Work Location: In person

Quick apply

Refine Your Search

regulatory affairs chemical jobs in mumbai maharashtra

Regulatory Affairs Manager

Regulatory Affairs – Chief Manager

DGM - Biologics External Manufacturing & Supply Operations

More jobs to discover

I want to receive the latest job alerts for regulatory affairs chemical in mumbai maharashtra

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected