The pharmaceutical industry continues to create exciting career opportunities for skilled professionals, especially in the field of Regulatory Affairs. If you are a B.Pharmacy graduate with experience in pharmaceutical documentation and compliance activities, a new opportunity has emerged in Ahmedabad, Gujarat.
A pharmaceutical company located in Gota, Ahmedabad is currently looking for a Regulatory Affairs Executive to strengthen its regulatory team. This position is suitable for candidates who possess 1 to 2 years of experience in the pharmaceutical industry and have hands-on knowledge of dossier preparation, stability documentation, validation support, and regulatory compliance processes.
For professionals aiming to build a long-term career in the pharmaceutical sector, Regulatory Affairs remains one of the most stable and rewarding career paths.
About the Regulatory Affairs Executive Role
Regulatory Affairs professionals act as a bridge between pharmaceutical companies and regulatory authorities. Their primary responsibility is ensuring that pharmaceutical products comply with all applicable regulations before they are marketed and distributed.
They play a critical role in product registrations, document preparation, compliance reviews, packaging approvals, and maintaining product quality standards throughout the product lifecycle.
As pharmaceutical exports continue to grow globally, organizations are increasingly seeking qualified Regulatory Affairs professionals who can manage documentation efficiently and ensure smooth regulatory submissions.
Job Details
Position: Regulatory Affairs Executive
Department: Regulatory Affairs
Location: Gota, Ahmedabad, Gujarat
Qualification: Bachelor of Pharmacy (B.Pharm)
Experience Required: 1–2 Years
Preferred Candidates: Female professionals with relevant pharmaceutical industry experience
Key Responsibilities
The selected candidate will be involved in multiple regulatory activities that support product registration and compliance management.
Regulatory Dossier Preparation
One of the major responsibilities of this role includes preparing and reviewing regulatory dossiers according to industry standards.
Candidates should be familiar with:
- CTD (Common Technical Document)
- ACTD (ASEAN Common Technical Document)
- Dossier compilation and review
- Regulatory document maintenance
- Submission support activities
Proper dossier preparation is essential for obtaining regulatory approvals and ensuring product compliance in different markets.
Stability Documentation Management
The Regulatory Affairs department works closely with quality and manufacturing teams to maintain accurate stability documentation.
Responsibilities may include:
- Stability protocol preparation
- Stability data review
- Stability report compilation
- Documentation tracking and maintenance
Strong attention to detail is essential while managing stability-related records.
Process Validation Documentation
Knowledge of process validation documentation is considered an advantage for this role.
The selected professional may assist with:
- Validation report review
- Manufacturing process compliance documentation
- Validation record maintenance
- Cross-functional coordination activities
Validation ensures that manufacturing processes consistently produce products meeting predefined quality standards.
Artwork and Packaging Compliance Review
Packaging compliance is a critical aspect of pharmaceutical regulations.
Key tasks may include:
- Artwork verification
- Label content review
- Packaging compliance checks
- Regulatory approval coordination
Accurate artwork review helps prevent compliance issues and supports patient safety.
Documentation Preparation and Review
The Regulatory Affairs Executive will also participate in preparing and reviewing important pharmaceutical documents.
Examples include:
- Batch Manufacturing Records (BMR)
- Batch Packaging Records (BPR)
- Product specifications
- Compliance documentation
- Product-related records
Strong documentation skills are highly valued in this position.
International Regulatory Documentation
Candidates with knowledge of international regulatory requirements may have an added advantage.
Documentation may involve:
- SMPC (Summary of Product Characteristics)
- Package inserts
- Product leaflets
- Product information documents
These documents are essential for product registration and commercialization in various international markets.
Additional Technical Activities
Professionals working in this role may also contribute to:
- AMV documentation activities
- CDP matching
- COA review
- MOA specifications management
- Finished product specification review
- Independent document preparation and verification
Required Skills
To succeed in this role, candidates should possess a combination of technical and professional skills.
Technical Skills
- Regulatory documentation expertise
- CTD and ACTD knowledge
- Stability documentation handling
- Validation documentation understanding
- Product registration support experience
- Compliance management knowledge
Professional Skills
- Excellent attention to detail
- Strong written communication skills
- Good organizational abilities
- Effective time management
- Team collaboration skills
- Ability to work independently
Employers highly value professionals who can maintain accuracy while managing large volumes of documentation.
Educational Qualification
Applicants should have:
Bachelor of Pharmacy (B.Pharm)
Additional certifications related to Regulatory Affairs, Quality Assurance, or Pharmaceutical Compliance can further enhance a candidate’s profile and improve career prospects.
Why Choose a Career in Regulatory Affairs?
Regulatory Affairs has become one of the fastest-growing domains within the pharmaceutical industry.
Some benefits of pursuing a Regulatory Affairs career include:
Stable Career Growth
Every pharmaceutical company requires regulatory professionals to manage compliance and product registrations.
Global Opportunities
Regulatory knowledge is valuable in both domestic and international pharmaceutical markets.
Continuous Learning
Professionals gain exposure to evolving regulatory guidelines and global compliance requirements.
Competitive Salary Growth
Experienced Regulatory Affairs professionals often enjoy strong salary progression as they move into senior roles.
Industry-Wide Relevance
Regulatory Affairs expertise remains valuable across pharmaceutical, biotechnology, medical device, and healthcare sectors.
Career Growth Path
Candidates joining as Regulatory Affairs Executives can progress into advanced positions such as:
- Senior Regulatory Affairs Executive
- Regulatory Affairs Specialist
- Regulatory Affairs Associate
- Dossier Management Specialist
- Regulatory Affairs Manager
- Global Regulatory Affairs Professional
With experience and continuous learning, professionals can build successful long-term careers in this field.
Tips for Applicants
Before applying, ensure that your resume clearly highlights:
- Regulatory Affairs experience
- CTD and ACTD knowledge
- Stability documentation expertise
- Validation support activities
- Product registration involvement
- Compliance documentation handling
- Educational qualifications
- Technical skills and software proficiency
A well-structured resume can significantly improve your chances of securing an interview.
Application Details
Interested candidates can submit their updated resumes through the contact details provided by the hiring organization.
Email: recruitment@laxaurabusiness.com
Contact Number: 9145221793
Applicants are advised to verify all job-related information directly with the employer before sharing personal documents or accepting employment offers.
Final Thoughts
Regulatory Affairs continues to be one of the most critical functions within the pharmaceutical industry. Organizations rely heavily on regulatory professionals to ensure compliance, maintain documentation standards, and support successful product registrations.
For B.Pharm graduates with 1 to 2 years of experience, this Ahmedabad-based Regulatory Affairs Executive opportunity offers a promising platform to enhance technical expertise and advance professionally.
If you are looking to strengthen your career in pharmaceutical compliance, dossier preparation, and regulatory documentation, this position could be an excellent next step toward achieving your professional goals.
Stay connected with JobsOnTheWay for the latest pharmaceutical, clinical research, regulatory affairs, pharmacovigilance, and healthcare career opportunities across India.
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