Regulatory Affairs Manager

2 weeks ago


Bengaluru, Karnataka, India PSI Full time

Job Description

You will focus on leading regulatory services for global research projects of novel medicinal products in India while joining our global team of regulatory and ethics submissions experts. Join our team and contribute to groundbreaking clinical research.

Office-based in Bangalore or Remote in India

Oversee preparation of clinical trial submission dossiers for regulatory authorities in India, including Import and Export license applications Communicate with regulatory authorities, project teams and vendors on regulatory-related matters Develop and review project planning documents & processes, including study timelines for India Track changes/amendments to legislative acts pertaining to clinical trials in India and timely notification of all parties involved Develop and maintain regulatory requirements database Perform quality control of regulatory dossiers Ensures accurate and time-bound reporting of safety issues to local authorities Train PSI staff in regulatory aspects of clinical trials Mentor and train junior regulatory staff Participate in the regulatory aspects of feasibility research, support Business Development at client presentations and bid defense meetings

Qualifications

University degree 5 years of hands-on experience with clinical trial submissions (independent preparation of submissions dossiers for DCGI, including preparation of application forms, Executive Summary, country-specific statement, as well as country-level customization of patient documents) Extensive experience in regulatory aspects of clinical research with profound knowledge of regulations pertaining to clinical trials in India Full working proficiency in English Proficiency in MS Office applications Ability to learn, plan and work in a dynamic team environment Communication, collaboration, and problem-solving skills

Additional Information

You will work closely with driven and dedicated cross-functional teams, get all support and ownership of your projects.



  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager IICareer Level - DIntroduction to Role:Join our International Regulatory Affairs team at AstraZeneca, where we are dedicated to delivering groundbreaking medicines to patients globally as efficiently as possible. An exciting opportunity awaits for a Regulatory Affairs Manager II. This role involves overseeing planning,...


  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager II (International Regulatory Affairs) Career Level - D Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, bold approaches are taken to bring crucial medicines to patients globally. The focus is on accelerating Regulatory approvals for new medicines efficiently so that no...


  • Bengaluru, Karnataka, India Biocon Full time

    We are hiring for dynamic individuals in Regulatory Affairs Department:Experience: 3 years up to 12 yearsDesignation: Senior Exec / Assistant Manager / Deputy ManagerQualification: M. Sc. / M. Pharma/ B.Pharma For Below Mentioned roles:Role 1: API Regulatory Affairs DMF filing / Submission. submission to global markets & handling health authority...


  • Bengaluru, Karnataka, India Biocon Full time

    We are hiring for dynamic individuals in Regulatory Affairs Department: Experience: 3 years up to 12 years Designation: Senior Exec / Assistant Manager / Deputy Manager Qualification: M. Sc. / M. Pharma/ B.Pharma For Below Mentioned roles:Role 1: API Regulatory Affairs DMF filing / Submission. submission to global markets & handling health authority queries....


  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager ICareer Level - DIntroduction to Role:Join our dynamic International Regulatory Affairs team at AstraZeneca, where we are committed to bringing life-changing medicines to patients across the globe. We have an exciting opportunity for a Regulatory Affairs Manager I to contribute to our mission. In this role, you will be...


  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager ICareer Level - DIntroduction to Role:Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a regulatory specialist with project management capabilities. This role is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will be expected to work...


  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor, if required. The...


  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a role that offers the opportunity to contribute to our drug development strategies and turn them into reality. As a regulatory specialist with project management capabilities, you will be responsible...


  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...


  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...


  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a regulatory specialist with project management capabilities. This role is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will be...


  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: iCMC Regulatory Affairs Manager Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as an iCMC Regulatory Affairs Manager. This is an exciting opportunity to innovate in a safe environment, where you will be part of a team with deep specialist knowledge and regulatory expertise. We are confident in what we know...


  • Bengaluru, Karnataka, India Biocon Full time

    Manager - Global Regulatory AffairsLocation: Head-Office, Bangalore, IndiaCompany: Biocon BiologicsAt Biocon Biologics, we are shaping the future of healthcare. As leaders in the biosimilars industry, our focus is always on the well-being of patients. Our goal is to positively impact a billion lives by fostering a culture of innovation, patient-centered...

  • Regulatory Affairs

    2 weeks ago


    Bengaluru, Karnataka, India AstraZeneca Full time

    Description The Regulatory Affairs Manager 1 with Business Development role sits in the Regulatory Business Development group and is of key importance in the delivery of AstraZeneca business development portfolio to ensure license transition in the most efficient and customer focused manner. The role comprises of two main accountabilities, described...


  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Associate ICareer Level - CIntroduction to Role:Join our International Regulatory Affairs Management (RAM) team as a Regulatory Affairs Associate I. This role offers an exciting opportunity to contribute to the development and approval of life-changing medicines for patients in international markets. As a Regulatory Affairs...


  • Bengaluru, Karnataka, India Biocon Full time

    Biocon Biologics is at the forefront of the healthcare industry revolution, placing patient needs above all else. Our goal is to positively impact the lives of billions by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. As a diverse global company, our employees are driven by purpose and passion to collaborate...


  • Bengaluru, Karnataka, India AstraZeneca Full time

    About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Position purpose For assigned products:...


  • Bengaluru, Karnataka, India ResMed Full time

    Summary:A Regulatory Affairs Administrative Assistant provides crucial support to regulatory affairs experts in managing compliance, records, and administrative tasks. They have a key role in ensuring the smooth operation of the regulatory department.Responsibilities and Accountabilities:Document Management: Assist in preparing, compiling, and maintaining...


  • Bengaluru, Karnataka, India Eli Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...

  • Regulatory Affairs Ba

    3 weeks ago


    Bengaluru, Karnataka, India CGI Group, Inc. Full time

    Position Description:Requirement Regulatory Affairs BARecruiter Name NikithaNjoyn ID J Primary Skills Regulatory Affairs BASecondary Skills Pharma DomainExperience 3-6+yrsNotice Period 0-30daysLocation Bangalore/ HyderabadDetailed Job Description Technical Skills: Regulatory Affairs 3+ Years Dossier 3+ Years Product Approval Life Cycle 3+ Years Regulatory...