Symbiotec Hiring Regulatory Affairs

Symbiotec RA Hiring | M.Pharm Jobs | Indore

Symbiotec hiring for API Regulatory Affairs roles in Indore. M.Pharm, B.Pharm, M.Sc candidates with 2–10 years experience can apply.

URL Slug: symbiotec-api-regulatory-affairs-dmf-dossier

Pharmaceutical Regulatory Affairs professionals with experience in API dossier preparation, DMF submissions, and global regulatory documentation now have a strong career opportunity in Indore. Symbiotec is hiring experienced candidates for API Regulatory Affairs roles focused on dossier compilation, regulatory lifecycle management, and compliance support for international pharmaceutical markets.

The company is looking for professionals with expertise in API Regulatory Affairs, CTD/eCTD documentation, DMF preparation, and global pharmaceutical compliance systems. Candidates with strong pharmaceutical documentation experience and regulatory submission knowledge can apply for this hiring opportunity.

Demand for Regulatory Affairs professionals continues to increase across API manufacturing companies due to growing global pharmaceutical exports and stringent international compliance requirements.

Company Overview

Symbiotec is a pharmaceutical company involved in API manufacturing and regulatory-focused pharmaceutical operations. The organization supports global pharmaceutical markets through quality manufacturing systems, regulatory documentation management, and compliance-driven operations.

The company is actively hiring professionals for its Regulatory Affairs – API department in Indore.

Regulatory Affairs departments play a critical role in pharmaceutical companies by ensuring products meet international regulatory standards before entering global markets.

Professionals working in API Regulatory Affairs gain exposure to:

Global pharmaceutical regulations
API dossier submissions
Drug Master File (DMF) preparation
CTD and eCTD documentation systems
Regulatory lifecycle management
International compliance frameworks
Pharmaceutical documentation systems

With increasing pharmaceutical exports from India, API Regulatory Affairs has become one of the highest-demand pharmaceutical career domains.

Job Role & Responsibilities

Symbiotec is hiring experienced professionals for the following role:

API Dossier / DMF – Regulatory Affairs

Candidates selected for this role will support API regulatory documentation, global dossier preparation, and compliance activities.

Key Responsibilities
Preparation and review of API dossiers and DMF documents
Compilation and submission of regulatory documentation for global markets
Coordination with QA, QC, Production, and R&D departments for dossier compilation
Preparation and management of CTD/eCTD documentation
Handling regulatory lifecycle management activities
Responding to deficiency letters and regulatory queries
Maintaining regulatory documentation records and databases
Ensuring compliance with international regulatory guidelines
Supporting pharmaceutical compliance and documentation activities

Candidates with strong documentation practices and pharmaceutical regulatory knowledge will have an advantage during the selection process.

Eligibility / Qualifications
Required Qualification

Candidates with the following educational qualifications are eligible:

M.Pharm
B.Pharm
M.Sc
Any Post Graduate Degree
Relevant Courses

Regulatory Affairs, Pharmaceutical Regulatory Affairs, Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Pharmaceutical Analysis, Pharmaceutical Documentation, API Regulatory Affairs, CTD Documentation, eCTD Submission Systems, Pharmaceutical Compliance, Drug Regulatory Affairs, Pharmaceutical Quality Systems

Experience Required
2 to 10 Years

Candidates with prior experience in pharmaceutical Regulatory Affairs, API dossier handling, or global regulatory submissions are preferred.

Required Skills

Candidates applying for this Regulatory Affairs role should possess:

Strong knowledge of API Regulatory Affairs
Experience in DMF and dossier preparation
Understanding of CEP documentation
Knowledge of CTD and eCTD formats
Regulatory lifecycle management exposure
Strong pharmaceutical documentation skills
Good communication and coordination abilities
Familiarity with international regulatory guidelines
Experience in responding to regulatory deficiencies and queries

Professionals with exposure to regulated pharmaceutical markets may receive preference.

Why Regulatory Affairs Is a High-Growth Pharma Career

Regulatory Affairs is one of the most important functions in the pharmaceutical industry because companies require strong documentation and compliance support to launch products in international markets.

API Regulatory Affairs professionals work on:

Drug Master Files (DMF)
API dossier submissions
Global regulatory documentation
CTD and eCTD submissions
Regulatory deficiency responses
Product lifecycle management
Compliance documentation
International pharmaceutical registrations

Growing demand in regulated markets such as the US, Europe, Latin America, and emerging global regions has significantly increased the need for experienced Regulatory Affairs professionals.

Candidates working in Regulatory Affairs often gain long-term career opportunities in:

Global pharmaceutical companies
API manufacturing organizations
Regulatory consulting firms
International compliance operations
Pharmaceutical documentation systems
Location & Salary
Job Location

Indore, Madhya Pradesh

Expected Salary

Based on current pharmaceutical industry standards for API Regulatory Affairs professionals in Indore, approximate salary ranges may include:

Regulatory Affairs Executive: ₹4 LPA to ₹6 LPA
Senior Regulatory Affairs Executive: ₹6 LPA to ₹10 LPA
Experienced API RA Professionals: ₹10 LPA+ depending on expertise and global submission exposure

Salary packages generally depend on:

Experience in DMF and dossier preparation
Exposure to regulated markets
CTD/eCTD expertise
Regulatory submission experience
Communication and compliance knowledge
Application Process

Interested candidates can apply by sharing their updated resume through email.

Email Application

📧 Jai.mirchandani@symbiotec.com

Candidates should clearly mention:

Current designation
Total Regulatory Affairs experience
API RA exposure
CTD/eCTD experience
DMF and dossier handling experience
Current CTC
Notice period

Candidates with immediate joining availability may receive preference.

Frequently Asked Questions (FAQs)
Which company is hiring for API Regulatory Affairs roles?

Symbiotec is hiring experienced professionals for API Regulatory Affairs positions in Indore.

What qualifications are eligible for this role?

Candidates with M.Pharm, B.Pharm, M.Sc, or any postgraduate qualification are eligible.

What experience is required?

The company is looking for candidates with 2 to 10 years of Regulatory Affairs experience.

What skills are required for this position?

Candidates should have knowledge of DMF preparation, API dossiers, CTD/eCTD documentation, and pharmaceutical regulatory compliance.

Is experience in global regulatory markets required?

Yes. Candidates with exposure to global regulatory documentation and international compliance systems are preferred.

What is the job location?

The job location is Indore, Madhya Pradesh.

Summary Table
Company          Symbiotec
Department      Vacancies Regulatory Affairs – API, DMF, Dossier Preparation
Qualification     M.Pharm, B.Pharm, M.Sc, Any Post Graduate
Experience         2–10 Years
Location             Indore