12 Oct
|
Naprod Life Sciences
|
Mumbai
12 Oct
Naprod Life Sciences
Mumbai
Company Description Titan, An Integrated Pharmaceutical Group, is a global pharmaceutical and generic formulation company specializing in the development and manufacturing of sustained and modified release pellets, DC granules, and taste-masked granules. The organization focuses on advanced formulation technologies that support high-quality, effective therapies.
Titan serves international markets and is trusted worldwide by healthcare partners and customers. The company emphasizes innovation, reliability, and regulatory standards across all its operations to ensure consistent product performance and patient safety.
Role Description This full-time, on-site Regulatory Affairs Manager role is based in Mumbai. The role involves overseeing regulatory strategies for pharmaceutical and generic formulations, preparing and coordinating regulatory submissions, and ensuring alignment with national and international regulatory requirements.
The Regulatory Affairs
Manager will collaborate with cross-functional teams in quality, manufacturing, and R&D; to maintain compliance, support new product registrations, and manage lifecycle updates for existing products.
Responsibilities include monitoring regulatory changes,
guiding internal teams on compliance expectations, and supporting audits and inspections with appropriate documentation and risk assessments.
Qualifications
- Candidates should possess strong knowledge of Regulatory Affairs and Regulatory Submissions for pharmaceutical and Anesthesia formulations.
- Candidates should possess a solid understanding of Regulatory Requirements and Regulatory Compliance in domestic and international markets.
- Candidates should possess experience working with and maintaining an effective Quality System in a pharmaceutical manufacturing workplace.
- Relevant academic background such as a degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field.
- Experience in managing product registrations, variations, and renewals with regulatory authorities.
- Strong analytical, documentation, and organizational skills, with attention to detail and accuracy.
- Ability to collaborate with cross-functional teams and communicate clearly with regulatory agencies and internal stakeholders.
- Prior experience in a similar regulatory role within the pharmaceutical industry is highly beneficial.
📌 Regulatory Affairs Manager (Mumbai)
🏢 Naprod Life Sciences
📍 Mumbai