Apothecon Pharmaceuticals Pvt. Ltd.
Apothecon Pharmaceuticals Pvt. Ltd., a fast-growing name in the pharmaceutical industry, is currently inviting applications for an Executive position in the Regulatory Affairs Department. This opportunity is ideal for experienced professionals looking to contribute their expertise in a dynamic, compliance-driven environment.
As a company committed to excellence in healthcare, Apothecon is known for its strong regulatory framework, quality-driven operations, and focus on global market expansion. With a robust portfolio in oral solids and parenteral formulations, the company continues to strengthen its presence in regulated markets like the United States.
Greeting from Apothecon Pharma…!!!
We have Vacancy in Regulatory Affairs Department at Apothecon Pharmaceuticals Pvt. Ltd.
The key criteria are mentioned below:
Department: Regulatory Affairs
Designation: Executive
Experience: 5 – 6 years
Qualification: B. Pharma / M. Pharma /M.SC
Candidate must have exposure in:
1.) Preparation and review of ANDA for US submission for Oral Solid Dosage form (Tablet /Capsule) / Parenteral Formulation.
2.) Responding to the ANDA deficiency.
3.) Review of CMC section of drug substance for ANDA submission.
4.) Submission of Post approval Changes (Viz- PAS, CBE-0, CBE -30)
5.) Review of Bioequivalence study protocol and report.
6.) Submission of Annual Report / PADER to FDA.
7.) Knowledge in eCTD software.
Those who match with the criteria, kindly send their CV along with their current CTC, Expected CTC and Notice Period / Serving terms details to [email protected] & [email protected].
Our team will get back to you if the mentioned Criteria match as per the requirements.
Candidate Profile:
We are looking for candidates who demonstrate strong regulatory knowledge, attention to detail, and familiarity with current FDA requirements. Prior experience in US regulatory submissions is essential. Candidates should also be well-versed in ICH guidelines, regulatory intelligence, and global submission formats.
Application Process:
Eligible candidates are encouraged to apply by sending the following 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 or details of current serving terms
Please forward your applications to the following email addresses:
📧 [email protected]
📧 [email protected]
Shortlisted candidates who meet the qualification and experience criteria will be contacted by our HR team for further discussion.
About Apothecon Pharmaceuticals Pvt. Ltd.:
Apothecon is a trusted pharmaceutical organization committed to providing high-quality and affordable medicines globally. With a focus on innovation, regulatory compliance, and continuous improvement, we strive to create value for patients, partners, and stakeholders alike.
Join Apothecon and be part of a company where your regulatory expertise will make a global impact.
Thanks,
Team HR
