India's DMPLOI - Jobs & Networking AppSP Accure Labs Pvt. Ltd., a rapidly growing pharmaceutical organization, is inviting applications from experienced professionals for its Regulatory Affairs Department. This recruitment drive offers excellent career opportunities for candidates with expertise in dossier preparation, product registrations, regulatory submissions, renewals, and variations for regulated and semi-regulated markets.
Candidates with relevant experience in Regulatory Affairs and a strong understanding of CTD/eCTD submissions are encouraged to apply.
About SP Accure Labs
SP Accure Labs Pvt. Ltd. is a leading pharmaceutical company focused on delivering high-quality healthcare solutions globally. The company specializes in regulatory compliance, product development, and international market expansion while maintaining stringent quality standards.
Website: www.spaccurelabs.com
Job Details Particulars
Details
Company Name
SP Accure Labs Pvt. Ltd.
Department
Regulatory Affairs
Positions
Jr. Executive, Sr. Executive, Assistant Manager
Experience Required
4–8 Years
Qualification
M.Sc, B.Pharm, D.Pharm, M.Pharm
Job Location
Telangana
Industry
Pharmaceutical
Employment Type
Full-Time
Key Responsibilities
Selected candidates will be responsible for:
Preparation and submission of CTD/eCTD dossiers.
Handling product registrations for regulated and semi-regulated markets.
Managing regulatory renewals and product variations.
Coordinating with global regulatory authorities.
Reviewing and compiling technical documentation as per regulatory requirements.
Ensuring compliance with international regulatory guidelines.
Supporting product lifecycle management activities.
Required Qualifications
Applicants should possess any of the following qualifications:
M.Sc
B.Pharm
D.Pharm
M.Pharm
Candidates must have 4 to 8 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.
Why Join SP Accure Labs?
Opportunity to work in international regulatory markets.
Exposure to CTD/eCTD submissions and global registrations.
Career growth in a reputed pharmaceutical organization.
Professional work environment with learning opportunities.
Competitive compensation package based on experience.
How to Apply?
Interested candidates can send their updated CV to:
📧 jobs@spaccurelabs.com
📞 +91 73966 44772
Interview Location
SP Accure Labs Pvt. Ltd.
Plot No. 12, Biotech Park, Phase-II,
Lalgadi Malakpet, Shameerpet,
Medchal-Malkajgiri District, Telangana.
Technical FAQs – Regulatory Affairs
1. What is CTD and eCTD in Regulatory Affairs?
CTD (Common Technical Document) is a standardized format used for regulatory submissions, while eCTD is its electronic version. These formats help pharmaceutical companies submit product registration dossiers efficiently to global regulatory authorities.
2. What are product variations in Regulatory Affairs?
Variations refer to post-approval changes made to a registered pharmaceutical product, such as manufacturing site changes, formulation modifications, packaging updates, or labeling revisions that require regulatory approval.
3. What is the difference between regulated and semi-regulated markets?
Regulated markets include countries with strict pharmaceutical regulations such as the USA, EU, Canada, and Australia. Semi-regulated markets have less stringent but structured regulatory requirements and include many countries in Asia, Africa, and Latin America.
4. What documents are typically included in a CTD dossier?
A CTD dossier generally includes:
Administrative Information
Quality Documentation (CMC)
Non-Clinical Studies
Clinical Studies
Product Information and Labeling Documents
5. What skills are essential for a Regulatory Affairs professional?
Key skills include:
CTD/eCTD dossier preparation
Regulatory submission management
Knowledge of global guidelines (ICH, USFDA, EMA)
Documentation and compliance expertise
Strong communication and project coordination skills
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