Regulatory Affairs Specialist
Job Description:
Job Description – Regulatory Affairs Specialist
Company: Concept Pharma Pvt. Ltd.
Position: Regulatory Affairs Specialist
Vacancies: 2
Experience: 5–10 Years
CTC (Budget): Negotiable
Location: Aurangabad
Key Responsibilities
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Lead and manage the compilation, preparation, and submission of regulatory dossiers for domestic and international markets in ACTD/CTD formats.
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Ensure full compliance with CDSCO regulations and global regulatory requirements for product registrations, variations, renewals, and post-approval changes.
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Coordinate with cross-functional teams including R&D, Quality Assurance, Production, and Analytical departments to collect technical data, stability studies, validation documents, and related regulatory inputs.
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Prepare, review, and maintain quality and technical documentation, including Module 3 (CMC) dossiers, risk assessments, validation reports, and compliance documents.
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Handle and respond to regulatory authority queries, deficiency letters, and follow-ups to ensure timely approvals.
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Maintain accurate regulatory submission trackers, records, and country-specific regulatory databases.
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Monitor changes in regulatory guidelines and ensure timely implementation across ongoing and future submissions.
Required Skills & Qualifications
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Educational Qualification: B.Pharm / M.Pharm / MSc in Pharmacy, Life Sciences, or related field (Regulatory Affairs specialization preferred).
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Strong technical knowledge of ACTD/CTD dossier preparation, formatting requirements, and regulatory submission standards.
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In-depth understanding of regulatory frameworks, application processes, and compliance documentation.
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Good communication and coordination skills to effectively interact with internal teams and external regulatory agencies.
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Ability to manage multiple submissions and meet strict regulatory timelines.
Preferred Skills
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Prior experience in handling export dossiers and ROW (Rest of World) regulatory filing strategies.
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Familiarity with electronic submissions (eCTD) and regulatory document management systems.
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Exposure to international regulatory authorities and multi-country submissions will be an added advantage.
Company Profile
These activities are supported with a strong infrastructure such as 5 manufacturing plants, 21 branch offices – cum – distribution centers, more than 300 strong marketing force throughout the country meeting 50,000 doctors every month supported by a network of around 1000 stockiest–cum–distributors. The company is putting a lot of thrust towards R & D efforts and has successfully launched few technologies, the first time in the country through its own government approved R&D centers. --- Group of Companies also have received three Export awards from the government and over a dozen awards from various organizations in recognition of its achievements.
Apply Now
- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.