Home
Communities
Companies
- Companies
  
  Discover best places to work
- Compare Companies
  
  Compare & find best workplace
- Add Office Photos
  
  Bring your workplace to life
- Add Company Benefits
  
  Highlight your company's perks
Reviews
- Company reviews
  
  Read reviews for 6L+ companies
- Write a review
  
  Rate your former or current company
Salaries
- Browse salaries
  
  Discover salaries for 6L+ companies
- Salary calculator
  
  Calculate your take home salary
- Are you paid fairly?
  
  Check your market value
- Share your salary
  
  Help other jobseekers
- Gratuity calculator
  
  Check your gratuity amount
- HRA calculator
  
  Check how much of your HRA is tax-free
- Salary hike calculator
  
  Check your salary hike
Interviews
- Company interviews
  
  Read interviews for 40K+ companies
- Campus placements
  
  Interviews questions for 1K+ colleges
- Share interview questions
  
  Contribute your interview questions
Jobs
Awards

WINNERS AWAITED!
- ABECA 2025
  
  WINNERS AWAITED!
  
  AmbitionBox Employee Choice Awards - 4th Edition
- ABECA 2024
  
  AmbitionBox Employee Choice Awards - 3rd Edition
- AmbitionBox Best Places to Work 2022
  
  2nd Edition
- AmbitionBox Best Places to Work 2021
  
  1st Edition

Add office photos

Employer? Claim Account for FREE

Syngene International

Compare

3.9

based on 1.9k Reviews

34 Syngene International Jobs

Team member, Regulatory Affairs

Syngene

3.9

based on 1.9k Reviews

5-10 years

Bangalore / Bengaluru

1 vacancy

Team member, Regulatory Affairs

Syngene International

posted 4d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy NDA Project Management Life Sciences Product Marketing EHS

+ 3 more

Job Description

Mandatory expectation for all roles as per Syngene safety guidelines

Overall adherence to safe practices and procedures of oneself and the teams aligned
Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards
Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
Compliance to Syngene s quality standards at all times
Hold self and their teams accountable for the achievement of safety goals
Govern and Review safety metrics from time to time

Core Purpose of the Role:

The candidate will combine his/her knowledge of scientific & regulatory guidelines, CMC regulatory and filing skills to ensure successful filing, registrations, and post-approval maintenance for the intended countries. The candidate will lead eCTD filing, Regulatory DMS and QMS system activities.

Role Accountabilities

The candidate s contribution will help bring the much-needed therapeutics to the unmet need of the patients, thereby positively impacting mankind. The candidate will be accountable for:

Pivotal CMC Regulatory support throughout the development cycle of the novel drugs space and generics space, including small molecule & biologics, in marketing authorization / DMF filing and lifecycle management, predominantly for Developed countries and for certain Emerging countries, based on the market requirement.
Research on regulatory requirements for new molecules / category of products based on business need in time-bound manner and provide feasibility/technical inputs to the team.
Identify requirements for IND, NDA, MAA, ANDA, ANADA and other Dossiers, prepare checklists, ensuring regulatory compliance.
Interact with stakeholders, collate necessary document, Review plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc, conduct thorough regulatory assessment, identify risks, communicate to team and client, and recommend corrective measures.
Plan and develop sections, compile, author, and Publish eCTD Dossiers. Ensure timely submission. Respond to regulatory agencies on a timely basis. Responsible for Regulatory project management.
Provide Regulatory strategy inputs to the team and the clients. Assessing the regulatory requirements for various business requirements as and when needed.
Maintain all regulatory filings, Product Marketing authorization renewals to ensure continuous validity. Maintain, and update product dossiers/DMFs as required to meet changes in internal systems, changes in regulatory guidelines.
Maintain Quality Agreement Tracker, prepare Quality Agreement Checklists, and review New Quality Agreements.
Train staff in regulatory policies or procedures. Develop and maintain standard operating procedures or local working practices.
Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
Attend training on environment, health, and safety (EHS) measures imparted by the company.
Traveling to other sites within Karnataka if necessary, though travel requirements are minimal.

Leadership Capabilities

Syngene Values

All employees will consistently demonstrate alignment with our core values

Excellence
Integrity
Professionalism

Specific requirements for this role

Experience
Demonstrated Capability
Education

Experience

Must have experience of 6 to 13 years in CMC Regulatory Affairs for small molecule API / Formulations (preferably in injectables) for US/Europe/Developed Markets
Must have hands-on experience in investigational medicinal products and marketing authorization.
Experience in Biologicals /ADC / veterinary drugs is a definite plus.

Skills and Capabilities

High-level English Proficiency in reading, writing, and communication
Hands-on Experience in eCTD. Experience in RDMS, EDMS & QMS is definite plus.
Thorough understanding of CMC (API & Drug Product) and skill in regulatory interpretations and application