Regulatory Affairs Officer/Executive

Gayatri

Human Resources

Immacule Lifesciences (P) Ltd.

(Address. Village Thanthewal, Ropar Road, Nalagarh,

Distt. - Solan, (H.P)-174101)

Mobile No :- +91-8278729004

Regulatory Affairs Officer/Executive

Key Responsibilities:

• Prepare, compile, review, and submit

  regulatory dossiers

  (CTD/eCTD formats) for

  OSD products

  for

  USFDA, MHRA (UK), and various ROW markets

  .
• Ensure

  timely and accurate

  submission of

  ANDA

  ,

  variation filings

  ,

  renewals

  , and

  annual reports

  .
• Coordinate with cross-functional teams (R&D, QC, QA, Production, etc.) to gather necessary documentation and technical data required for submissions.
  
• Review

  technical documents

  , product development reports, validation protocols/reports, stability data, and other regulatory documents for accuracy and compliance.
• Maintain knowledge of

  regulatory requirements and guidelines

  for target markets (US, UK/EU, LATAM, Africa, Southeast Asia, etc.).
• Handle

  regulatory queries and deficiency letters

  from agencies such as USFDA and MHRA, and provide timely and effective responses.
• Monitor changes in regulatory requirements and assess their impact on product registration and compliance.
  
• Maintain and update the

  regulatory database

  and

  track submission timelines and approvals

  .
• Support in product lifecycle management and post-approval changes.
  
• Liaise with external regulatory consultants, agents, and local partners as needed for market-specific requirements.
  

Required Skills & Competencies:

• In-depth knowledge

  of international regulatory requirements and guidelines (ICH, USFDA, MHRA, WHO, etc.).
• Strong experience with

  CTD/eCTD

  dossier compilation and submissions.
• Expertise in

  Oral Solid Dosage (OSD)

  products.
• Familiarity with submission platforms like

  ESG (FDA)

  ,

  MHRA Portal

  , etc.
• Good understanding of

  GMP, GLP, and GDP

  practices.
• Excellent

  documentation

  ,

  communication

  , and

  interpersonal skills

  .
• Strong

  attention to detail

  , organizational skills, and ability to manage multiple projects.
• Proficient in MS Office (Word, Excel, PowerPoint).
  

Preferred Qualifications:

• Prior experience in a

  Regulatory Affairs role in a pharmaceutical manufacturing company

  with exposure to regulated and semi-regulated markets.
• Experience dealing with

  regulatory authorities

  and handling

  regulatory audits

  is a plus.
• Knowledge of

  labeling requirements

  ,

  CMC documentation

  , and

  QbD submissions

  will be an added advantage.

Gayatri

Human Resources

Immacule Lifesciences (P) Ltd.

(Address. Village Thanthewal, Ropar Road, Nalagarh,

Distt. - Solan, (H.P)-174101)

Mobile No :- +91-8278729004