Assistant Manager

Honour Lab; Anakapalli; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Honour Lab in India seeks a qualified professional with an M.Sc. in Organic Chemistry or an equivalent degree to join our regulatory affairs team. The role focuses on core regulatory experience for API submissions and ensures alignment with global regulatory requirements.

The candidate will identify gaps in DMFs, handle electronic submissions, and conduct training for plant personnel on current regulatory requirements. Collaboration across cross-functional teams is essential.

Qualifications

• Must hold an M.Sc. in Organic Chemistry or an equivalent degree.
• Minimum core regulatory experience in API submissions.
• Experience identifying gaps during DMF preparation and review.
• Experience handling electronic submissions.
• Experience conducting training sessions on regulatory requirements.
• Experience assessing change controls and defining regulatory strategies.
• Experience handling customer calls and queries related to regulatory matters.
• Experience in regulatory deficiencies responses and audits.

Responsibilities

• Stay updated on current global regulatory requirements for API submissions.
• Identify gaps in DMFs during submission preparation and review.
• Manage electronic regulatory submissions.
• Conduct training for plant personnel on regulatory requirements.
• Assess change controls and define regulatory strategies.
• Handle customer calls and troubleshoot regulatory queries.
• Respond to regulatory deficiencies.
• Participate in technology transfer meetings and collaborate with cross-functional teams.
• Participate in regulatory and customer audits.

Skills

Chemistry Knowledge

Communication Skills

Listening and Teamwork

Soft Skills

Education

M.Sc. (Organic Chemistry) or Equivalent

Job description

Qualification : Should be M.Sc. (Organic Chemistry) or Equivalent

Looking for core regulatory experience candidates

Competencies Required

• Chemistry Knowledge (A foundational understanding of chemistry and should be able to understand chemical properties and characteristics of the API)
• Communication Skills (Effective communication, both written and verbal)
• Listening and Teamwork
• Soft Skills (Adaptability, and interpersonal skills for effective interaction with colleagues, regulatory agencies, and other stakeholders)

Job Responsibilities

• Should be well versed with current Global Regulatory requirements for API submission.
• Should be having experience in identifying gaps during preparation and review of DMFs required for regulatory submissions.
• Should be having experience on handling electronic submissions.
• Should be having experience in conducting training sessions for plant personnel on current regulatory requirements
• Should be having experience in assessing change controls and defining regulatory strategies.
• Should be having experience in handling customer calls and troubleshoot the customer queries.
• Should be having experience in handling response to Regulatory deficiencies
• Should be having experience in participation of technology transfer meetings and collaborating with Cross function teams.
• Should be having experience in participation of Regulatory and Customer audits as a part of Regulatory Compliance.