Apply now for Executive – Regulatory Affairs at Apothecon Pharma. Must have FDA, ANDA, eCTD experience. 5–6 years required. Submit CV to join a top pharma firm.
💼 Regulatory Affairs Executive Job at Apothecon Pharmaceuticals | FDA, ANDA, and eCTD Expertise Required
Are you an experienced Regulatory Affairs Specialist looking to elevate your career in the global pharmaceutical industry? Apothecon Pharmaceuticals Pvt. Ltd., a rapidly expanding pharmaceutical company, is actively hiring for the position of Executive – Regulatory Affairs. This opportunity is tailored for professionals with a strong background in ANDA submissions, FDA compliance, and eCTD dossier management.
If you have 5–6 years of regulatory experience, this role provides the platform to work on advanced filings for oral solid dosage forms and parenteral formulations for regulated markets like the United States.
🏢 About Apothecon Pharmaceuticals Pvt. Ltd.
Apothecon is a globally recognized pharmaceutical company dedicated to quality, innovation, and regulatory excellence. With a core focus on regulated markets, particularly the U.S. FDA, the company maintains a rich pipeline in oral solids and injectables, ensuring timely, compliant submissions and market approvals.
Apothecon’s Regulatory Affairs team plays a vital role in enabling global access to safe and effective medicines. Working here means being part of a compliance-driven, performance-focused organization that values expertise and scientific rigor.
📌 Job Details:
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Department: Regulatory Affairs
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Designation: Executive
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Location: [Corporate office or plant location, if applicable]
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Experience Required: 5 – 6 years
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Qualification: B.Pharm / M.Pharm / M.Sc
🛠️ Key Responsibilities:
This Regulatory Affairs Executive role involves direct ownership of high-stakes submission activities. The ideal candidate will be responsible for:
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Preparation and review of ANDA (Abbreviated New Drug Application) for oral solid dosage forms (tablets, capsules) and parenteral products.
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Responding to FDA ANDA deficiencies (Information Requests, Complete Response Letters).
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Review and authoring of CMC (Chemistry, Manufacturing, and Controls) sections of drug substance and drug product.
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Handling Post-Approval Changes, including:
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PAS (Prior Approval Supplement)
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CBE-30 (Changes Being Effected in 30 Days)
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CBE-0 (Immediate Implementation)
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Reviewing bioequivalence study protocols and reports.
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Preparing and submitting Annual Reports and PADERs (Periodic Adverse Drug Experience Reports) to the FDA.
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Proficiency in eCTD (electronic Common Technical Document) software and tools for compiling and submitting dossiers.
👤 Candidate Profile:
We are looking for candidates who demonstrate:
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Strong regulatory knowledge and attention to detail.
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In-depth understanding of USFDA guidelines, 21 CFR Part 314, and ICH Q series.
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Proven experience in ANDA lifecycle management.
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Proficiency in global submission formats including ACTD/eCTD.
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Prior exposure to regulatory intelligence, dossier strategy planning, and cross-functional coordination.
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Familiarity with publishing tools such as Extedo, Lorenz docuBridge, or Veeva Vault RIM.
📧 How to Apply:
Interested and eligible candidates are invited to apply by sending the following details to the provided emails:
Required Documents:
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Updated Resume/CV
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Current CTC (Cost to Company)
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Expected CTC
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Notice Period / Current Serving Terms
📩 Send your applications to:
📆 Deadline: Rolling application – early submissions encouraged!
🏆 Why Join Apothecon?
Joining Apothecon’s Regulatory Affairs team means working with a company that prioritizes global compliance, streamlined processes, and strategic expansion. You will be part of a team that is:
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Focused on regulated markets like the U.S., Canada, and Europe.
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Involved in complex ANDA and post-approval submission strategies.
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Valued for thought leadership and innovation in regulatory science.
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Supported by advanced regulatory tools and training programs.
This role opens doors to senior roles in global regulatory strategy, project leadership, and regulatory operations in multinational companies. Professionals skilled in ANDA and eCTD workflows are among the most in-demand in the pharma industry today.
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Apothecon is not just offering a job; it’s offering a chance to make a global impact through your regulatory knowledge. If you’re ready to bring value-driven compliance to life-saving products, we want to hear from you.
Submit your application today and take the next step in your regulatory career journey.
