DRA Officer: The pharmaceutical industry is one of the fastest-growing sectors globally, and Regulatory Affairs professionals play a critical role in ensuring that medicines meet all required safety, quality, and compliance standards before reaching the market. If you are a pharmacy graduate or postgraduate looking to establish a strong career in Regulatory Affairs, Brawn Laboratories is offering an excellent opportunity for the position of DRA Officer.
This position is ideal for candidates with knowledge of dossier preparation, CTD/eCTD submissions, regulatory documentation, and pharmaceutical compliance requirements. Professionals passionate about pharmaceutical regulations and global submission standards can gain valuable industry exposure through this role.
About Brawn Laboratories
Brawn Laboratories is a recognized pharmaceutical company engaged in the development, manufacturing, and marketing of high-quality pharmaceutical products. The company focuses on maintaining international quality standards and regulatory compliance across various markets.
The organization offers a professional work environment where employees gain practical exposure to pharmaceutical operations, regulatory systems, dossier preparation, and coordination with healthcare authorities. Working in such an environment helps professionals strengthen their expertise in the field of Drug Regulatory Affairs.
Job Details DRA Officer
Position: DRA Officer
Industry: Pharmaceutical & Life Sciences
Department: Healthcare & Life Sciences
Employment Type: Full Time, Permanent
Education: B.Pharma, M.Pharma
Role Category: Healthcare & Life Sciences – Other
Job Overview DRA Officer
The DRA Officer will be responsible for handling regulatory documentation, dossier preparation, and submission activities while ensuring compliance with applicable pharmaceutical guidelines and regulations. The candidate will work closely with multiple departments including Quality Assurance, Production, Research & Development, and Packaging to collect and organize documents required for regulatory submissions.
The role also involves responding to regulatory authority queries and ensuring that all submissions are accurate, complete, and compliant with international standards such as CTD, ACTD, and eCTD formats.
This opportunity is particularly beneficial for candidates aiming to develop long-term careers in:
- Drug Regulatory Affairs
- Pharmaceutical Documentation
- Global Regulatory Submissions
- Pharmaceutical Compliance
- International Market Registration
Key Responsibilities of a DRA Officer
The selected candidate will perform several important regulatory functions within the organization. Major responsibilities include:
1. Preparation and Submission of Regulatory Dossiers
The candidate will prepare regulatory dossiers for product registration and approval processes. This includes organizing technical documents, reviewing data accuracy, and ensuring proper formatting before submission to regulatory authorities.
Responsibilities may include:
- Compilation of product dossiers
- Document verification and review
- Submission planning and coordination
- Preparation of product registration files
2. Handling Regulatory Authority Queries
Regulatory agencies may request clarifications or additional documentation during product approval processes. The DRA Officer will coordinate responses and ensure timely submission of required information.
This includes:
- Reviewing authority observations
- Coordinating corrective documentation
- Preparing response letters
- Tracking query resolution timelines
3. Knowledge of CTD/ACTD/eCTD Formats
A strong understanding of pharmaceutical submission formats is essential for this role.
CTD (Common Technical Document): Common Technical Document is an internationally accepted format used for pharmaceutical product registration.
ACTD (ASEAN Common Technical Dossier): ASEAN Common Technical Dossier is commonly used for pharmaceutical submissions in ASEAN countries.
eCTD (Electronic Common Technical Document): Electronic Common Technical Document is the electronic version of CTD used for digital regulatory submissions.
The candidate should understand dossier structure, document formatting, and submission requirements associated with these formats.
Coordination with Internal Departments
The DRA Officer will regularly interact with different departments to collect necessary documents and technical information.
Departments involved may include:
- Quality Assurance (QA)
- Quality Control (QC)
- Research & Development (R&D)
- Manufacturing
- Packaging Development
- Analytical Development
Strong communication and coordination skills are essential for maintaining submission timelines and ensuring documentation accuracy.
Regulatory Compliance Responsibilities
Regulatory compliance is a critical aspect of pharmaceutical operations. The selected candidate must ensure that all documents and submissions follow applicable national and international guidelines.
Responsibilities include:
- Maintaining updated regulatory records
- Ensuring compliance with pharmaceutical regulations
- Monitoring guideline updates
- Supporting audit and inspection activities
- Maintaining documentation consistency
Educational Qualifications
Candidates applying for this position should possess the following qualifications:
Undergraduate Qualification
- Bachelor of Pharmacy in any specialization
Postgraduate Qualification
- Master of Pharmacy in any specialization
Candidates with academic backgrounds in Pharmacology, Pharmaceutics, Pharmaceutical Chemistry, or Regulatory Affairs may have additional advantages.
Required Skills
The company is looking for candidates with the following professional skills:
- Dossier Preparation
- Regulatory Affairs Knowledge
- Drug Regulatory Affairs
- CTD Documentation
- ACTD Submissions
- eCTD Submission Handling
- Regulatory Compliance
- Documentation Management
- Technical Writing
- Coordination Skills
- Pharmaceutical Documentation Review
Important Technical Knowledge for Regulatory Professionals
To succeed in Drug Regulatory Affairs, candidates should understand:
- Pharmaceutical registration processes
- International regulatory guidelines
- Product lifecycle management
- Stability documentation
- Quality documentation requirements
- Labeling and packaging regulations
- Submission tracking systems
Knowledge of global regulatory markets can provide additional career growth opportunities.
Career Scope in Drug Regulatory Affairs
Drug Regulatory Affairs is one of the most promising career fields in the pharmaceutical industry. Regulatory professionals are essential for ensuring that pharmaceutical products meet safety and legal requirements before commercial launch.
Career opportunities after gaining experience include:
- Regulatory Affairs Executive
- Senior DRA Officer
- Regulatory Affairs Manager
- Global Regulatory Specialist
- Compliance Specialist
- Pharmaceutical Documentation Expert
With increasing global pharmaceutical regulations, skilled Regulatory Affairs professionals are in high demand across pharmaceutical companies, CROs, and healthcare organizations.
Why This Opportunity is Valuable
Joining Brawn Laboratories as a DRA Officer provides:
- Industry exposure in pharmaceutical regulations
- Experience with global dossier formats
- Practical regulatory submission knowledge
- Opportunities for professional growth
- Hands-on documentation experience
- Coordination experience across pharmaceutical departments
This role can significantly strengthen a candidate’s profile for future opportunities in Regulatory Affairs and pharmaceutical compliance
Who Should Apply?
This position is suitable for:
- Freshers with knowledge of Regulatory Affairs
- Experienced DRA professionals
- Pharmacy graduates seeking pharmaceutical industry exposure
- M.Pharm candidates interested in documentation and compliance
- Candidates preparing for careers in international regulatory affairs
Conclusion
The DRA Officer position at Brawn Laboratories is an excellent career opportunity for pharmacy professionals looking to establish themselves in the field of Drug Regulatory Affairs. With responsibilities involving dossier preparation, regulatory submissions, compliance management, and authority coordination, this role offers strong learning potential and long-term career growth in the pharmaceutical industry.
Candidates with knowledge of CTD, ACTD, and eCTD formats along with strong documentation and coordination skills are encouraged to explore this opportunity and build a successful career in pharmaceutical regulatory affairs.
