Apply now for Regulatory Affairs Executive Jobs at Aculife Healthcare Ahmedabad. Pharma professionals with 6 months to 2 years experience eligible.
Company: Aculife Healthcare Pvt. Ltd. (A Nirma Group Company)
Position: Regulatory Affairs Executive / Officer
Qualification: M.Pharm / B.Pharm / M.Sc.
Location: Ahmedabad, Gujarat
Experience: 6 months to 2 years
Job Type: Full-time
Application Mode: Email Application
Job Status: Verified
About Aculife Healthcare Pvt. Ltd.
Aculife Healthcare Pvt. Ltd. is one of the most respected and fast-growing pharmaceutical companies in India. Aculife operates under the prestigious Nirma Group, a conglomerate known for its commitment to quality and innovation across multiple industries. With state-of-the-art manufacturing facilities, a robust research and development team, and a presence in more than 70 countries, Aculife has become a trusted name in the global healthcare industry. Regulatory Affairs Executive Jobs at Aculife Healthcare
The company specializes in the development, manufacturing, and marketing of a wide range of pharmaceutical and healthcare products. Its core business areas include injectables, IV fluids, and various therapeutic formulations that meet international quality standards. Regulatory Affairs Executive Jobs at Aculife Healthcare
Aculife’s commitment to regulatory excellence, global compliance, and patient safety has made it one of the preferred destinations for aspiring professionals in Regulatory Affairs. The organization provides immense opportunities for learning, professional growth, and international exposure. Regulatory Affairs Executive Jobs at Aculife Healthcare
About the Job – Regulatory Affairs Executive / Officer
Aculife Healthcare Pvt. Ltd. is currently inviting applications for the position of Regulatory Affairs Executive / Officer at its Head Office in Ahmedabad, Gujarat.
This opportunity is ideal for candidates with 6 months to 2 years of experience in International Regulatory Affairs (IRA) who wish to build a long-term career in the pharmaceutical regulatory domain.
As a Regulatory Affairs Executive, you will play a key role in ensuring that Aculife’s pharmaceutical products comply with international regulatory standards. You will work closely with global teams, handle technical documentation, and manage regulatory submissions for international markets such as LATAM, Brazil, Mexico, and the European Union (EU). Regulatory Affairs Executive Jobs at Aculife Healthcare
Key Responsibilities
The Regulatory Affairs Executive at Aculife Healthcare will be responsible for a broad range of tasks aimed at ensuring global regulatory compliance. The main duties and responsibilities include: Regulatory Affairs Executive Jobs at Aculife Healthcare
- Dossier Compilation and Review
- Prepare, compile, and review registration dossiers according to country-specific regulatory guidelines.
- Ensure that all documentation meets the latest standards and is audit-ready.
- International Regulatory Submissions
- Manage regulatory submissions for LATAM (Brazil, Mexico) and European Union markets.
- Coordinate closely with international regulatory authorities and ensure timely dossier submissions.
- Documentation Management
- Review critical technical and regulatory documents including:
- Drug Master Files (DMF)
- Product Development Reports
- Batch Manufacturing Records (BMR) and Batch Packing Records (BPR)
- Analytical Method Validation Reports
- Specifications, Standard Testing Procedures (STP), and Stability Reports
- Bioequivalence (BE) Study Reports
- Maintain document integrity and ensure alignment with the company’s quality management system.
- Review critical technical and regulatory documents including:
- Regulatory Queries and Responses
- Prepare accurate and timely responses to deficiency letters or regulatory authority queries.
- Coordinate with cross-functional teams to provide scientific and technical justifications where required.
- Post-Approval Activities
- Manage post-approval changes and variations.
- Ensure continuous compliance with global regulatory requirements.
- Artwork and Packaging Review
- Review and approve packaging artwork and labeling to ensure alignment with approved dossiers and market-specific regulations.
- Collaboration and Coordination
- Work closely with overseas regulatory teams, agents, and distributors.
- Facilitate smooth communication between internal departments and international counterparts for successful product registrations.
- Regulatory Database Maintenance
- Maintain and update the central regulatory database for all submitted and approved dossiers.
- Track the status of product registrations and renewals.
Preferred Candidate Profile
Aculife Healthcare is looking for detail-oriented and self-driven professionals with a passion for regulatory operations. The ideal candidate should meet the following requirements: Regulatory Affairs Executive Jobs at Aculife Healthcare
- Qualification: M.Pharm / B.Pharm / M.Sc. (Life Sciences preferred)
- Experience: 6 months to 2 years in International Regulatory Affairs (IRA)
- Skills and Knowledge:
- Strong understanding of regulatory guidelines and submission requirements for LATAM and EU markets
- Proficiency in dossier compilation and variation submission
- Excellent technical writing and documentation skills
- Familiarity with regulatory databases and submission tracking systems
- Good communication and coordination abilities for dealing with global teams and regulatory agencies
- Analytical mindset with a strong sense of accuracy and compliance
Why Choose Aculife Healthcare?
Working with Aculife Healthcare offers a unique opportunity to be part of a company that values innovation, integrity, and collaboration. As part of the Nirma Group, Aculife ensures long-term career stability and growth for its employees. Regulatory Affairs Executive Jobs at Aculife Healthcare
Here are some compelling reasons to join Aculife:
- Global Exposure: Work on international regulatory submissions covering markets such as the European Union, Brazil, Mexico, and other LATAM countries.
- Learning Environment: Continuous training and professional development to enhance your technical and regulatory knowledge.
- Career Growth: Opportunities to progress into senior regulatory positions within the company.
- Dynamic Work Culture: A supportive and collaborative environment that values creativity and teamwork.
- Competitive Compensation: Attractive salary package based on skills, qualifications, and industry standards.
Employees at Aculife Healthcare are encouraged to take ownership of their projects and develop leadership skills while contributing to the company’s mission of delivering high-quality healthcare solutions worldwide. Regulatory Affairs Executive Jobs at Aculife Healthcare
About the Work Location
This position is based at Aculife Healthcare’s Head Office in Ahmedabad, Gujarat, a city known for its growing pharmaceutical and biotechnology sector. The Ahmedabad facility is equipped with modern infrastructure, cutting-edge technology, and a research-driven environment that supports innovation and regulatory excellence. Regulatory Affairs Executive Jobs at Aculife Healthcare
Working in Ahmedabad also offers professionals access to a thriving industrial ecosystem, excellent connectivity, and a high quality of life, making it an ideal place for career growth in the pharmaceutical domain. Regulatory Affairs Executive Jobs at Aculife Healthcare
Ideal Candidate Attributes
A successful candidate for this role will possess:
- A thorough understanding of international regulatory frameworks.
- Ability to manage multiple projects and priorities effectively.
- Attention to detail and strong documentation discipline.
- Team collaboration and cross-functional communication skills.
- Adaptability to new regulatory technologies and tools.
- Commitment to maintaining high-quality compliance standards.
Career Benefits at Aculife Healthcare
When you join Aculife, you become part of a global team that values your contribution and supports your professional journey. Some of the additional benefits include: Regulatory Affairs Executive Jobs at Aculife Healthcare
- Comprehensive exposure to global regulatory operations.
- Hands-on experience with dossier preparation and product registration across multiple markets.
- Access to international regulatory databases and submission systems.
- Continuous professional development through structured training programs.
- A platform to work with highly experienced regulatory professionals and mentors.
How to Apply
If you meet the eligibility criteria and are interested in building a career in Regulatory Affairs with Aculife Healthcare Pvt. Ltd., you can apply through email. Regulatory Affairs Executive Jobs at Aculife Healthcare
Follow the steps below to apply:
- Prepare an updated resume highlighting your education, work experience, and relevant skills in regulatory affairs.
- Include a short cover letter introducing yourself and explaining your interest in the Regulatory Affairs Executive position.
- Send your application to the official email ID provided below.
Email Address: satabdeerath@aculife.co.in
Subject Line: Application for Regulatory Affairs – Ahmedabad
Candidates are advised to ensure their resumes are up to date and include all relevant details such as educational background, previous project involvement, and specific experience with LATAM or EU regulatory submissions. Regulatory Affairs Executive Jobs at Aculife Healthcare
Only shortlisted candidates will be contacted for the next stages of the recruitment process.
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
