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NecLife

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7 NecLife Jobs

AM/DM

8-11 years

Dera Bassi

1 vacancy

AM/DM

NecLife

posted 24d ago

Job Role Insights

Fixed timing

Job Description

Regulatory Submissions:


  1. Prepare, review, and submit regulatory documents for APIs, including:
    • Drug Master Files (DMFs) US DMF (Type II), EU CEPs, Canadian DMFs, and others.
    • Registration dossiers as per region-specific requirements (e.g., CTD, eCTD formats).
  2. Coordinate with internal teams to compile technical data for submissions.
  3. Provide timely responses to health authority queries and deficiency letters.

Compliance & Documentation:


  1. Ensure all APIs comply with global regulatory standards such as FDA, EMA, TGA, Health Canada, and ICH guidelines.
  2. Maintain accurate and up-to-date regulatory documentation, including technical and quality-related information.
  3. Oversee regulatory change management for APIs, ensuring compliance with variation guidelines.

Cross-Functional Collaboration:


  1. Work closely with R&D, Quality Assurance, Quality Control, and Production teams to gather data and ensure regulatory compliance throughout the product lifecycle.
  2. Provide regulatory guidance during the development of new APIs and during technology transfer activities.

Audits & Inspections:


  1. Support regulatory agency inspections and customer audits by providing required documentation and ensuring compliance.
  2. Address regulatory findings and implement corrective actions to mitigate compliance risks.

Strategy & Updates:


  1. Stay updated on global regulatory requirements and communicate changes to internal stakeholders.
  2. Develop regulatory strategies to support API product development and commercialization in key markets.


Employment Type: Full Time, Permanent

Read full job description

NecLife Interview Questions & Tips

Prepare for NecLife Assistant Manager roles with real interview advice

Top NecLife Assistant Manager Interview Questions

Q1. What are environment compliances to maintain in industries
Q2. What are basis treatment techniques for waste water COD
Q3. What are basis parameters of ZLD as per PPCB.
View all 29 questions

What people at NecLife are saying

3.1
 Rating based on 14 Assistant Manager reviews

Likes

Mobile Allowed Punjab & Surronding people can survive Ladies can survive

Dislikes

salary Toxic work culture Promotions increments security

  • Salary - Poor
  • +5 more
Read 14 Assistant Manager reviews

Assistant Manager salary at NecLife

reported by 51 employees with 10-15 years exp.
₹4 L/yr - ₹12 L/yr
10% less than the average Assistant Manager Salary in India
View more details

What NecLife employees are saying about work life

based on 556 employees
52%
71%
61%
99%
Strict timing
Monday to Saturday
No travel
Day Shift
View more insights

NecLife Benefits

Free Transport
Job Training
Health Insurance
Soft Skill Training
Cafeteria
Free Food +6 more
View more benefits

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