Apply now for Assistant Manager – Regulatory Affairs (US Market) at Senores Pharmaceuticals Ltd in Ahmedabad. 5–10 years of pharma regulatory experience required.
🚀 Join Senores Pharmaceuticals – Assistant Manager (Regulatory Affairs, US Market)
Are you a seasoned regulatory affairs professional seeking a career that combines purpose, precision, and global impact? Senores Pharmaceuticals Ltd, a rapidly growing name in the pharmaceutical industry, invites applications for the role of Assistant Manager – Regulatory Affairs (US Market) at its state-of-the-art office in Ahmedabad, Gujarat.
With a strong commitment to regulatory compliance, market expansion, and patient safety, Senores is the right place to accelerate your pharmaceutical career.
🏢 About Senores Pharmaceuticals Ltd
Senores Pharmaceuticals Ltd is a leading pharmaceutical company with a proven track record of excellence in formulation development, R&D, and global regulatory compliance. We are focused on developing, manufacturing, and marketing high-quality generics for international markets including the United States, Europe, and emerging markets.
Our teams work tirelessly to deliver value to patients and healthcare providers through scientific innovation and quality assurance.
🎯 Position Overview
Job Title: Assistant Manager – Regulatory Affairs (US Market)
Location: Ahmedabad, Gujarat
Experience: 5–10 Years in US Regulatory Affairs
Education: Master’s in Pharmacy (M.Pharm)
Department: Regulatory Affairs – US Market
✅ Key Responsibilities
As the Assistant Manager – Regulatory Affairs, your core responsibilities will include:
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Preparation, compilation, and submission of ANDA filings (Abbreviated New Drug Applications) for the US FDA.
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Review of CMC sections (Chemistry, Manufacturing and Controls) for drug substance and drug product dossiers.
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Handling post-approval changes including PAS (Prior Approval Supplements), CBE-30 (Changes Being Effected), and annual reports.
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Responding to FDA deficiency letters (Information Request / Complete Response Letters).
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Coordination with formulation, analytical, manufacturing, and quality teams to ensure timely regulatory compliance.
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Knowledge of eCTD submission formats, lifecycle management, and regulatory documentation.
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Keeping up to date with US FDA guidance documents and ICH guidelines.
🧠 Ideal Candidate Profile
The ideal candidate for this role is:
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A M.Pharm graduate with 5–10 years of hands-on experience in US market regulatory affairs.
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Proficient in preparing and submitting ANDA dossiers.
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Strong understanding of US FDA regulations, Orange Book listings, and regulatory strategy.
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Experienced in working with eCTD software, Adobe Acrobat, and submission portals.
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Well-versed with GMP compliance, drug master files (DMFs), and technical document review.
🌐 Why Choose a Career with Senores Pharmaceuticals?
At Senores, we don’t just offer jobs – we offer career growth, leadership opportunities, and the chance to work on regulatory projects with global significance. When you join Senores, you become part of:
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A high-performance regulatory team that ensures global market entry success.
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A company that values continuous learning, career development, and employee well-being.
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Opportunities to participate in FDA audits, regulatory inspections, and cross-functional product launches.
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A supportive work environment where your work in regulatory affairs directly contributes to global patient safety and product success.
📬 How to Apply
Are you ready to elevate your career with one of India’s most promising pharmaceutical firms?
📧 Send your updated CV to: hr@senorespharma.com
📌 Include the following in your email:
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Updated Resume/CV
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Current CTC & Expected CTC
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Notice Period / Serving Terms
Deadline to apply: As soon as possible. Shortlisted candidates will be contacted for interviews.
📍 Location Insights – Ahmedabad, Gujarat
Senores Pharmaceuticals is located in Ahmedabad, one of India’s top pharmaceutical hubs, home to major R&D centers and manufacturing plants. Living and working in Ahmedabad gives professionals:
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Access to top pharma talent pools
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Lower cost of living compared to metro cities
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Opportunities for career advancement within India’s regulatory and compliance capital
🎓 Bonus: Skills to Strengthen Before Joining
Boost your regulatory career by upskilling in:
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eCTD publishing software (like Extedo, GlobalSubmit, Liquent)
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FDA guidance documents and compliance updates
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Regulatory Intelligence & Competitive Intelligence tools
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ICH Q8, Q9, Q10 guideline comprehension
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Regulatory audit preparedness and mock audits
These skills will make your transition into Senores seamless and will strengthen your role in the US regulatory landscape.
Working in Regulatory Affairs for the US pharmaceutical market is a high-impact career path, offering both stability and long-term growth. At Senores Pharmaceuticals, you don’t just manage documents—you play a critical role in ensuring that life-saving medications reach global patients compliantly and efficiently.
If you’re an ambitious regulatory professional seeking your next big break, this is your opportunity to lead, innovate, and grow.
Don’t wait – take the next step in your career. Apply today and be part of a mission that matters.
