Looking for rewarding pharma jobs in India? ACME Generics is hiring experienced Regulatory Affairs professionals for EU Market operations in Ahmedabad. This opportunity is ideal for candidates seeking pharmaceutical careers with global exposure, regulatory expertise, and long-term professional growth.
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About the Company
ACME Generics is a well-established pharmaceutical organization known for its commitment to quality, innovation, and regulatory excellence.
The company operates with a strong focus on global healthcare standards and delivers pharmaceutical products across multiple international markets.
With a reputation for regulatory compliance, robust quality systems, and continuous improvement, ACME Generics provides professionals with opportunities to work on complex regulatory projects while contributing to global healthcare initiatives.
The organization promotes a culture of learning, collaboration, and career advancement within the pharmaceutical industry.
Professionals seeking pharma jobs, QA jobs, QC jobs, production jobs, and regulatory affairs opportunities can benefit from the company’s growth-oriented environment and international exposure.
Job Details
- Company Name: ACME Generics
- Position: Regulatory Affairs Executive / Senior Executive – EU Market
- Experience: 3–10 Years
- Qualification: B.Pharm, M.Pharm
- Location: Ahmedabad, Gujarat, India
- Work Type: On-site
- Industry: Pharmaceutical
- Preferred Industry: Pharmaceutical OSD / Injectable Industry
Job Description
ACME Generics is actively recruiting experienced Regulatory Affairs professionals to support EU market submissions and lifecycle management activities.
The role involves regulatory documentation, dossier preparation, submission management, and coordination with cross-functional teams to ensure compliance with international pharmaceutical regulations.
Regulatory Affairs Executive / Senior Executive – EU Market
- Department: Regulatory Affairs
- Market: European Union (EU)
- Role: Regulatory Affairs Executive / Senior Executive
- Experience: 3–10 Years
- Education/Qualification: B.Pharm / M.Pharm
Skills/Qualifications
- Strong knowledge of EU regulatory guidelines and procedures
- Experience with eCTD publishing and submissions
- Understanding of pharmaceutical formulation dossiers
- Knowledge of lifecycle management activities
- Experience in variations and renewals submissions
- Familiarity with deficiency response handling
- Understanding of SmPC, PIL, labeling requirements
- Excellent documentation skills
- Strong verbal and written communication skills
- Analytical and problem-solving abilities
- Effective time management skills
- Cross-functional team coordination experience
- Regulatory compliance expertise
- Experience with DCP and MRP procedures preferred
Key Responsibilities
- Prepare EU dossiers in eCTD and NeeS formats
- Review and submit regulatory applications
- Manage variations and renewals activities
- Handle deficiency response submissions
- Support PSUR and PBRER submissions
- Compile Modules 1 to 5 documentation
- Coordinate with R&D, QA, QC, and Production
- Review labeling and packaging compliance
- Monitor regulatory submission timelines
- Maintain regulatory databases accurately
- Track EU regulatory updates
- Support audits and inspections
- Communicate with EU authorities and partners
- Ensure compliance with regulatory requirements
Benefits/Perks
- Excellent career growth opportunities
- Exposure to international regulatory markets
- Hands-on experience with EU submissions
- Collaborative work environment
- Continuous learning opportunities
- Competitive compensation package
- Cross-functional industry exposure
- Professional development support
- Global regulatory expertise development
- Long-term career stability
How to Apply
Interested candidates who meet the eligibility criteria can apply by sending their updated CV to the official recruitment email below:
Email: pratik.joshi@acmegenerics.in
Candidates with experience in EU regulatory affairs, eCTD submissions, and pharmaceutical dossier management are encouraged to apply at the earliest.
For more pharmaceutical job opportunities, visit Pharma Recruiter: Pharma Recruiter
Apply today and advance your career in global pharmaceutical regulatory affairs.
Why You Should Join
Joining ACME Generics offers an opportunity to work in a professionally managed pharmaceutical organization focused on quality, compliance, and innovation.
Employees gain valuable exposure to international regulatory frameworks while working alongside experienced industry professionals.
The company provides a stable career path, learning-driven culture, and opportunities to contribute to regulatory projects impacting multiple global markets.
FAQs
Who can apply for this position?
Candidates holding B.Pharm or M.Pharm qualifications with 3–10 years of Regulatory Affairs experience in the pharmaceutical industry can apply.
Is EU regulatory experience mandatory?
Yes. Experience in EU market submissions, lifecycle management, and regulatory compliance is highly preferred.
Is this a walk-in interview opportunity?
No walk-in interview details have been provided. Interested candidates should apply through the official email address.
What career growth opportunities are available?
Selected candidates will gain international regulatory exposure, develop expertise in EU submissions, and work on advanced pharmaceutical compliance projects.
