Looking to advance your career in pharmaceutical regulatory affairs? ACME Generics is hiring experienced professionals for the role of Regulatory Affairs Executive / Senior Executive (EU Market) in Ahmedabad.
This opportunity is ideal for candidates with strong expertise in EU submissions, eCTD publishing, and lifecycle management who are seeking global exposure in pharma careers.
About ACME Generics
ACME Generics Official Website
ACME Generics is a reputed pharmaceutical company known for its focus on quality, innovation, and regulatory excellence. The organization operates across international markets, delivering high-quality pharmaceutical products that meet stringent global standards.
Key highlights:
- Strong presence in global pharmaceutical markets
- Expertise in regulatory compliance and submissions
- Advanced quality systems and manufacturing practices
- Growth-oriented and collaborative work culture
ACME Generics provides professionals with opportunities to work on complex regulatory projects and contribute to global healthcare initiatives.
Job Details
- Company Name: ACME Generics
- Position: Regulatory Affairs Executive / Senior Executive – EU Market
- Location: Ahmedabad, Gujarat, India
- Experience: 3–10 Years
- Qualification: B.Pharm / M.Pharm
- Work Type: On-site
- Industry: Pharmaceutical (OSD / Injectable preferred)
Job Description
ACME Generics is actively recruiting Regulatory Affairs professionals to handle EU market submissions and lifecycle management activities.
The role involves:
- Regulatory dossier preparation
- eCTD and NeeS submissions
- Variations and renewals handling
- Coordination with internal departments
Skills & Qualifications
Candidates must have:
- Strong knowledge of EU regulatory guidelines
- Experience with eCTD publishing and submissions
- Expertise in dossier preparation (Modules 1–5)
- Knowledge of lifecycle management processes
- Experience in variations and renewals
- Understanding of SmPC, PIL, and labeling requirements
- Familiarity with DCP and MRP procedures
- Strong communication and documentation skills
- Analytical and problem-solving abilities
Key Responsibilities
- Prepare and submit EU regulatory dossiers
- Manage lifecycle activities (variations, renewals)
- Handle deficiency responses
- Support PSUR and PBRER submissions
- Coordinate with R&D, QA, QC, and Production teams
- Ensure compliance with EU regulations
- Maintain regulatory databases
- Track submission timelines and updates
- Support audits and inspections
Benefits of Joining ACME Generics
- Exposure to international EU regulatory markets
- Hands-on experience with global submissions
- Strong career growth opportunities
- Competitive compensation package
- Learning-driven work environment
- Cross-functional exposure
- Long-term career stability
How to Apply
Interested candidates can apply by sending their updated CV to:
- Email: pratik.joshi@acmegenerics.in
Candidates with EU regulatory experience and strong dossier knowledge are encouraged to apply as soon as possible.
Why Choose ACME Generics?
Working with ACME Generics provides a unique opportunity to build expertise in global pharmaceutical regulations. Employees gain hands-on experience in EU submissions, collaborate with industry experts, and contribute to international healthcare standards.
The company’s focus on innovation, compliance, and professional development makes it a preferred employer in the pharmaceutical sector.
Authoritative Sources
- ACME Generics Official Website
- European Medicines Agency (EMA) Guidelines
- ICH (International Council for Harmonisation) Regulatory Standards
FAQs
1. Who is eligible for this role?
Candidates with B.Pharm or M.Pharm and 3–10 years of Regulatory Affairs experience.
2. Is EU regulatory experience required?
Yes, experience in EU submissions, lifecycle management, and compliance is highly preferred.
3. What is the job location?
Ahmedabad, Gujarat, India.
4. Is this a walk-in opportunity?
No, candidates must apply via email.
5. What kind of experience is preferred?
Experience in eCTD submissions, dossier preparation, variations, renewals, and EU regulatory processes.
