PROPHARMEX INC.,
Website:
propharmex.com
Job details:
Company Description Propharmex Inc. is a pharmaceutical CDMO focused on niche, complex generics, and specialty products for global markets. Headquartered in Canada, with state-of-the-art R&D laboratories in Hyderabad, India, the company delivers end-to-end services from product ideation and regulatory strategy to development, manufacturing, submissions, and product life cycle management. Propharmex provides product development, analytical services, regulatory support for US, Canada, EU, and other regions, BA-BE study coordination, and contract manufacturing oversight. The company also offers specialized services for the Canadian market, including NPN filings, regulatory submissions, MDAL applications, and 3PL services. Commitment, compliance, and confidentiality guide its operations, with a focus on quality, continuous supply, and long-term partnerships.
Role Description This is a full-time Regulatory Affairs Associate role based in Hyderabad. The Regulatory Affairs Associate will assist in preparing, reviewing, and maintaining regulatory documentation and dossiers for multiple regions, ensuring accuracy, completeness, and alignment with applicable guidelines. The role includes coordinating regulatory submissions, tracking their progress, and supporting responses to health authority queries in collaboration with cross-functional teams such as R&D, QA, and manufacturing. Day-to-day tasks involve monitoring changes in global regulatory requirements, supporting compliance activities, and contributing to regulatory strategy for new and existing products. The associate will also help maintain internal regulatory records, support audits and inspections, and contribute to continuous improvement of regulatory processes and templates.
Qualifications
- Candidates should possess skills in Regulatory Documentation and Regulatory Submissions for pharmaceutical products across multiple global markets.
- Candidates should possess skills in Regulatory Compliance and Regulatory Requirements, including interpreting guidelines and ensuring adherence to regional regulations.
- Candidates should possess skills in Regulatory Affairs, with the ability to support strategies for product development, approvals, and life cycle management.
- Strong attention to detail, organizational skills, and the ability to manage multiple projects and timelines in a regulated environment.
- Effective written and verbal communication skills for preparing clear dossiers and collaborating with internal and external stakeholders.
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related discipline; prior experience in pharmaceutical regulatory affairs is an asset.
- Familiarity with regulatory pathways and formats for US, Canada, EU, and other international markets is preferred.
- Proficiency with common office and documentation tools, and comfort working in a hybrid setting with cross-cultural teams.
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