Regulatory Affairs Manager

1 month ago

Bengaluru, India PSI CRO 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

  • 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. If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

  • Regulatory Affairs Manager

    2 weeks ago

    Bengaluru, India SurgeWay Biosciences Full time

    Company DescriptionSurgeWay Biosciences Pvt Ltd is an established exporter of Pharmaceutical Drugs and Niche Healthcare Products. With a strong track record of domestic and international operations spanning 40 years, SurgeWay is led by a dynamic young team that brings a professional approach and long-term business growth outlook. Our expertise in regulatory...

  • Regulatory Affairs Manager

    2 weeks ago

    Bengaluru, India SurgeWay Biosciences Full time

    Company DescriptionSurgeWay Biosciences Pvt Ltd is an established exporter of Pharmaceutical Drugs and Niche Healthcare Products. With a strong track record of domestic and international operations spanning 40 years, SurgeWay is led by a dynamic young team that brings a professional approach and long-term business growth outlook. Our expertise in regulatory...

  • Regulatory Affairs Associate

    1 month ago

    Bengaluru, India Parexel Full time

    **Regulatory Affairs Associate** 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: - Submission delivery strategy - Review of documents - Analysis of...

  • Regulatory Affairs Intern

    1 week ago

    Bengaluru, India Novozymes Full time

    Rethink your impact - Are you passionate about working in multifunctional team supporting business in legislative landscape, then you might be our new Regulatory Affairs Intern. - Work for a cause, not just a company - Novozymes is the world’s leading provider of industrial enzymes and microorganisms. Together with our customers, partners, and the global...

  • Regulatory Affairs Ba

    2 months ago

    Bengaluru, India CGI Full time

    **Regulatory Affairs BA**: **Category**: Software Development/ Engineering **Main location**: India, Karnataka, Bangalore **Position ID**: J1122-2759 **Employment Type**: Full Time **Position Description**: - Requirement Regulatory Affairs BA - Recruiter Name Nikitha - Njoyn ID J1122-2759 - Primary Skills Regulatory Affairs BA - Secondary Skills Pharma...

  • Regulatory Affairs Ba

    2 days ago

    Bengaluru, India Emprego IN Full time

    **Job Description** Regulatory Affairs BA Position Description Requirement Regulatory Affairs BA Recruiter Name Nikitha Njoyn ID J1122-2759 Primary Skills Regulatory Affairs BA Secondary Skills Pharma Domain Experience 3-6+yrs Notice Period 0-30days Location Bangalore/ Hyderabad Detailed Job Description Technical Skills: - Regulatory Affairs - 3+...

  • Regulatory Affairs Ba

    2 months ago

    Bengaluru, India CGI Group, Inc. Full time

    **Position Description**: Requirement Regulatory Affairs BA Recruiter Name Nikitha Njoyn ID J1122-2759 Primary Skills Regulatory Affairs BA Secondary Skills Pharma Domain Experience 3-6+yrs Notice Period 0-30days Location Bangalore/ Hyderabad Detailed Job Description Technical Skills: - Regulatory Affairs - 3+ Years - Dossier - 3+ Years - Product...

  • Manager Global Regulatory Affairs

    2 weeks ago

    Bengaluru, India Biocon Biologics Full time

    Manager – Global Regulatory AffairsLocation – Head-Office, Bangalore, INBIOCON BIOLOGICSBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation,...

  • Manager Global Regulatory Affairs

    2 weeks ago

    Bengaluru, India Biocon Biologics Full time

    Manager – Global Regulatory AffairsLocation – Head-Office, Bangalore, INBIOCON BIOLOGICSBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation,...

  • Manager Global Regulatory Affairs

    6 days ago

    Bengaluru, India Biocon Biologics Full time

    Manager – Global Regulatory AffairsLocation – Head-Office, Bangalore, INBIOCON BIOLOGICSBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation,...

  • Manager Global Regulatory Affairs

    7 days ago

    Bengaluru, India Biocon Biologics Full time

    Manager – Global Regulatory AffairsLocation – Head-Office, Bangalore, INBIOCON BIOLOGICSBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation,...

  • Manager Global Regulatory Affairs

    6 days ago

    Bengaluru, India Biocon Biologics Full time

    Manager – Global Regulatory Affairs Location – Head-Office, Bangalore, IN BIOCON BIOLOGICS Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable...

  • Regulatory Affairs Ba

    3 days ago

    Bengaluru, India CGI Full time

    Regulatory Affairs Business Analyst **Technical Skills**: - Regulatory Affairs - 3+ Years - Regulatory Publishing, CMC, eCTD - 3+ Years - Regulatory Process - 3+ Years **Technical Skill Capability Level**: - Communication - 4 (Capability Level (Scale of 1 -5)) - Working with US Teams - 4 (Capability Level (Scale of 1 -5)) Insights you can act on While...

  • Regulatory Affairs Professional

    12 hours ago

    Bengaluru, India Siemens Healthineers Full time

    **Internal Title**:Regulatory Affairs Professional **External Title**:Deputy General Manager **Position Summary** To perform regulatory tasks as applicable to SHPL products pertaining to regulating authorities like radiation safety related certification from Atomic Energy Regulatory Board (AERB) for Zone India (India, Bangladesh, Nepal, Sri Lanka &...

  • Regulatory Affairs Associate

    1 month ago

    Bengaluru, India Parexel Full time

    **_Regulatory Affairs Associate _**: **Experience: RIM**: **Relevant experience in Regulatory and should be willing to work in EU Shifts (12:00 - 9.00 PM)**: - **Experience of handling RIM tools - Veeva Vault specifically.**: - **Basic Regulatory knowledge on regulations and Health Authorities.**: - **Excellent communication skills.** **Knowledge and...

  • Regulatory Affairs Associate

    2 months ago

    Bengaluru, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

  • Communications Partner

    7 days ago

    Bengaluru, India Novo Nordisk Full time

    **Department - **IO RA **The Position** As a Regulatory Communications Partner, you will create, implement, and drive communication strategies and initiatives across IO-RA (International Operations Regulatory Affairs). Furthermore, you will support & contribute towards organisation change management (OCM) as well as drive cross-organizational project...

  • Regulatory Affairs Executive

    12 hours ago

    Bengaluru, India Indian Institute of Science, Bangalore Full time

    **Responsibilities**: - Work closely with Engineering team through product development process and design activities - Author/participate in the design validation and process validations, IQ, OQ, PQ. - Prepare, review risk management files and support risk management activities including hazard analysis and FMEA. - Identify relevant guidance documents,...

  • Lead - Regulatory Affairs

    2 weeks ago

    Bengaluru, India Indegene Full time

    Title: Lead - Regulatory Affairs Date: May 10, 2024 Location: Bangalore, KA, IN We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a...

  • Lead - Regulatory Affairs

    7 days ago

    Bengaluru, India Indegene Full time

    Title: Lead - Regulatory Affairs Date: May 10, 2024 Location: Bangalore, KA, IN We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a...