Synthimed Lab Private Limited, a growing pharmaceutical organization committed to excellence, compliance, and innovation, has announced exciting career opportunities for experienced professionals in the Drug Regulatory Affairs Department. Candidates with strong exposure to regulatory submissions for international markets and API regulatory documentation are encouraged to apply.

This recruitment drive offers excellent opportunities for professionals seeking long-term growth in the pharmaceutical regulatory sector.

Company Overview

Company Name: Synthimed Lab Private Limited

Industry: Pharmaceuticals / APIs

Location: Derabassi (Near Chandigarh), SAS Nagar, Punjab – 140507

Website: www.synthimed.com

Synthimed Lab is known for maintaining high standards in pharmaceutical manufacturing, regulatory compliance, and global market expansion.

Available Positions

1. Manager – Drug Regulatory Affairs

Experience Required: 12–14 Years

2. Executive – Drug Regulatory Affairs

Experience Required: 3–6 Years

Educational Qualification

Candidates should possess any of the following qualifications:

M.Pharm

M.Sc (Organic Chemistry)

Eligibility Criteria

Applicants must have:

Experience in Regulatory Affairs within the pharmaceutical/API industry.

Exposure to regulated markets including:

United States (US)

European Union (EU)

Rest of World (ROW) Markets

Strong understanding of regulatory submissions and documentation.

API regulatory exposure is mandatory.

Key Responsibilities

Manager – Drug Regulatory Affairs

Lead regulatory submission activities for global markets.

Review and approve regulatory dossiers.

Coordinate with R&D, Quality Assurance, and Manufacturing teams.

Ensure compliance with international regulatory requirements.

Manage lifecycle maintenance of regulatory filings.

Executive – Drug Regulatory Affairs

Prepare and compile regulatory submissions.

Maintain product registrations and variations.

Support dossier preparation and documentation activities.

Coordinate with cross-functional departments for regulatory compliance.

Track regulatory commitments and timelines.

Skills Required

Knowledge of CTD/eCTD submissions.

Understanding of USFDA, EMA, and ROW regulations.

Regulatory documentation and dossier compilation.

API regulatory filing experience.

Strong communication and coordination skills.

Analytical and problem-solving abilities.

How to Apply

Interested candidates can send their updated CV to:

📧 anku@synthimed.com

📧 astha.trivedi@synthimed.com

Contact Numbers

📞 8894970684

📞 8968374200

Job Location

Synthimed Lab Private Limited

Derabassi (Near Chandigarh)

SAS Nagar, Punjab – 140507

Technical FAQs

1. What is the role of Drug Regulatory Affairs in the pharmaceutical industry?

Drug Regulatory Affairs ensures that pharmaceutical products comply with all regulatory requirements and obtain approvals from health authorities before commercialization.

2. What is CTD and eCTD?

CTD (Common Technical Document) is a standardized format for regulatory submissions, while eCTD is the electronic version used by regulatory agencies such as USFDA and EMA.

3. Why is API regulatory experience important?

API regulatory experience helps professionals manage regulatory filings, DMFs, compliance documentation, and global registration requirements for active pharmaceutical ingredients.

4. What regulatory markets exposure is required for this role?

Candidates should have experience working with regulated markets such as the US, EU, and ROW, including submission, maintenance, and compliance activities.

5. What are the major regulatory agencies involved in pharmaceutical approvals?

Major agencies include:

USFDA (United States)

EMA (European Union)

MHRA (United Kingdom)

Health Canada

TGA (Australia)

Various ROW regulatory authorities