Regulatory Affairs Specialist

Jobtailor; Satara; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Jobtailor in India seeks a Regulatory Affairs professional to manage LOA references for DMFs, draft submissions for FDA/Health Canada/NMPA, and maintain regulatory databases. You will support dossier preparation, data packages, and annual reports while coordinating with global teams.

The role requires strong eCTD writing skills, regulatory knowledge of USP/EP/JP/ChP, and experience in pharmaceutical packaging components. Travel is minimal, with frequent cross-department collaboration.

Qualifications

• Masters or Bachelors in science with regulatory exposure.
• Experience with regulatory affairs or R&D or QA/QC in pharma packaging components.
• Knowledge of eCTD dossier preparation and technical writing.

Responsibilities

• Assess LOA requests for DMFs and reference letters.
• Prepare LOA drafts for US-FDA, Health Canada and NMPA China.
• Maintain LOA database and share analyses with sales teams.
• Prepare weekly DMF data packages and assist annual DMF reports.
• Ensure annual washing validation reports are prepared and transformed for submissions.
• Arrange samples and testing data for submissions.
• Support dossier preparation and responses to Health Authorities.
• Oversee notarization/legalization of quality certificates and documents.
• Maintain ISO database and assist staff with standards copies.
• Track updates to standards and support CDS/COAs implementation.
• Regulatory knowledge per USP/EP/JP/ChP and ICH guidelines.
• Monitor Health Authority updates including FDA letters.
• Provide regulatory support to employees and customers.
• Participate in internal regulatory-support projects.
• Update internal employee training.

Skills

Regulatory Affairs

eCTD Dossier Preparation

Technical Writing

Data Analysis

Document Management

Quality Assurance

Regulatory Compliance

Pharmaceutical Packaging Knowledge

Validation Report Preparation

Health Authority Submissions

Education

Master's or Bachelor's degree in a scientific discipline

Tools

LOA Database

ISO Standards

Regulatory Submission Tools

Data Management Systems

Job description

• Assess customer requests for Letters of Authorization (LOA) to reference Drug Master Files (DMFs)


• Issue LOA drafts for US-FDA, Health Canada and NMPA China


• Maintain the LOA database, prepare analyses and share them with sales teams


• Prepare weekly data packages for DMFs and support annual DMF reports


• Ensure availability of annual washing validation reports, review them, and transform them into submission formats


• Arrange samples and testing data required for submissions


• Support preparation of dossiers and responses to Health Authorities


• Manage timely notarization and legalization of quality certificates and documents


• Maintain the ISO database and support employees in obtaining working copies of standards


• Track standards updates and revisions and support implementation regarding CDS and COAs


• Apply regulatory knowledge concerning USP, EP, JP, ChP, and guidelines from EU, USA, China, Canada, ICH, and other health authorities


• Monitor updates from Health Authorities, including FDA warning letters and authorization of innovative products


• Provide regulatory support to employees and customers


• Participate in internal regulatory-support projects


• Update internal employee training

Requirements

• Master or Bachelor degree in a scientific discipline (chemistry, biochemistry, biomedical sciences, biology, …) +3 years of experience in Regulatory Affairs or R&D or QA/QC in pharmaceutical packaging components or pharmaceutical industry


• Willing to develop detailed regulatory knowledge about packaging components, specifically rubber but also aluminium


• Skilled in eCTD dossier preparation & technical writing


• Punctual in maintenance and storage of regulatory files and documents


• Good spoken and written English


• Willingness to maintain frequent internal contacts with colleagues in various departments and parts of the world


• Only sporadic traveling (less than 5 % of working time)

Core Competencies

Demonstrates expertise in Regulatory Affairs with a strong focus on eCTD Dossier Preparation, Technical Writing, and compliance with international health authority guidelines. Proficient in managing regulatory documentation and providing support across various departments within the pharmaceutical industry.

Highest-signal resume keywords

• Regulatory Affairs Experience


• ECTD Dossier Preparation


• Technical Writing


• Regulatory Knowledge of USP, EP, JP, ChP


• ISO Database Maintenance

Hard Skills

• Regulatory Affairs


• ECTD Dossier Preparation


• Technical Writing


• Data Analysis


• Document Management


• Quality Assurance


• Regulatory Compliance


• Pharmaceutical Packaging Knowledge


• Validation Report Preparation


• Health Authority Submission

Soft Skills

• Punctuality


• Effective Communication


• Collaboration


• Interpersonal Skills


• Adaptability

Industry Keywords

• Drug Master Files


• Letters of Authorization


• Health Authorities


• FDA


• Health Canada


• NMPA China


• ICH Guidelines


• Pharmaceutical Industry


• Quality Certificates


• Regulatory Support

Tools & Technologies

• LOA Database


• ISO Standards


• Regulatory Submission Tools


• Data Management Systems