Regulatory Officer

6 months ago


Bengaluru, India PSI CRO Full time

Company Description

We are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.

**Job Description**:
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products **in India**, while taking a step further in your professional career.

This is an Office-based position located in Bangalore, India

**Your role**:

- Communicate with regulatory authorities, project teams and vendors on regulatory-related matters.
- Track the regulatory project documentation flow.
- Review documents to greenlight IP release to sites.
- Manage safety reporting to authorities.
- Deliver regulatory training to project teams.
- Assist with feasibility research and business development requests.

**Qualifications**:

- College/University degree or an equivalent combination of education, training and experience.
- Full working proficiency in English.
- Ability to learn, plan and work in a dynamic team environment.
- Communication, collaboration, and problem-solving skills.

Additional Information

PSI is a passionate, organically grown, and award-winning full-service CRO who dares to be different. As a dynamic and global company, we bring together more than 2,700 driven and dedicated experts across 60 countries working collectively to help make a positive impact on patient lives.

**How are we different?**

PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.

**Being a Part of the Team**

As a part of the PSI team, you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.

You will receive continuous support from your global peers and join a fast-paced, innovative, and results-oriented working environment with lean communication lines. We pride ourselves on being approachable, receptive to new ideas, and open to feedback.

**Growth Opportunities**

PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

**The PSI Advantage**

PSI CRO has been named a 2022 CRO Leadership Award Champion in the categories of Compatibility, Quality, and Reliability across two respondent groups (Overall and Small Pharma). This is the fourth year in a row that PSI CRO received CRO Leadership Awards in all 5 categories, also including Expertise and Capabilities. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

**Unique Opportunity**

If you’re looking to advance your career in clinical research at a company growing organically into new regions around the world, we would love to hear from you Global CROs don’t expand their business to new locations every day, so don’t miss your chance.



  • Bengaluru, Karnataka, India May I Help You Full time

    Compliance Specialist Job DescriptionAt May I Help You, we are seeking a highly skilled Compliance Specialist to join our team.As a Compliance Specialist, you will be responsible for ensuring our organization adheres to all relevant regulations, laws, and policies. Your primary goal will be to maintain a culture of compliance within our organization.Key...

  • Compliance Officer

    3 weeks ago


    Bengaluru, Karnataka, India DocsApp Full time

    About the Role:As a Compliance Officer - Legal & Regulatory at DocsApp, you will play a pivotal role in ensuring our company's adherence to relevant laws, regulations, and industry standards. You will collaborate closely with cross-functional teams to develop and implement effective compliance strategies, policies, and protocols.Key Responsibilities:Develop...


  • Bengaluru, Karnataka, India F335 Deutsche India Private Limited, Bangalore Branch Full time

    Our company, F335 Deutsche India Private Limited, Bangalore Branch, is seeking a highly skilled Regulatory Compliance Officer to join our team. As a key member of our operations department, you will play a critical role in ensuring that all our services are executed in a timely and professional manner, with risk minimized and client experience positive.The...


  • Bengaluru, Karnataka, India Brickwork Ratings Full time

    Company OverviewBrickwork Ratings is one of India's leading credit rating agencies, committed to providing the investment community with products and services needed to make informed investment decisions.The company was established in 2007 and is headquartered in Bengaluru with a pan-India presence. It has a strong team of experienced credit analysts,...

  • Compliance Officer

    2 days ago


    Bengaluru, Karnataka, India GoKhana Full time

    About GoKhana - ToBox Ventures Pvt LtdGoKhana is a cutting-edge B2B technology company that empowers corporates with end-to-end food management solutions. Our innovative platform streamlines the digitization of corporate cafeterias and eateries in tech parks, ensuring seamless integration with food partners and corporate clients.We are committed to...

  • Regulatory Affairs

    1 week ago


    Bengaluru / Bangalore, Chennai, India Ajay Bhardwaj (Proprietor Of Ocean Biomed) Full time

    Summary:The Regulatory Affairs Officer ensures that pharmaceutical products comply with industry regulations. This role involves preparing and submitting regulatory documents, managing compliance, and maintaining product approvals.Roles and Responsibilities:Regulatory Submissions: Prepare and submit regulatory documents for product approvals and...


  • Bengaluru, Karnataka, India State Street Full time

    Who we are looking for The Reporting and Issue Management Coordinator, Officer, will report directly to the Head of Corporate Audit (CA) Practices and work closely with the Audit Plan and Methodology Governance Lead. This role is responsible for coordinating all regulatory validation tollgates, tracking and reporting on the status of Corporate Audit...


  • Bengaluru, Karnataka, India Elanco Full time

    At Elanco, we foster a collaborative and inclusive work environment that values diversity and champions innovation.We're seeking a skilled Regulatory Publishing Specialist to join our team.As a Regulatory Publishing Specialist, you will work closely with our Global Regulatory and R&D Organization to publish documents, manage processes, and develop positive...


  • Bengaluru, Karnataka, India ResMed Full time

    The Regulatory Affairs function at ResMed plays a crucial role in ensuring compliance with regulatory frameworks and delivering optimal regulatory strategies for portfolio planning, active regulatory intelligence, and excellence in execution.Key Responsibilities:Support and maintain internal and government databases relevant to ResMed's operations.Define and...


  • Bengaluru, Karnataka, India Celegence Full time

    Job Description for Senior Medical Writer Key Responsibilities:Develop and deliver high-quality regulatory documents for Medical Devices across therapeutic areasEngage with internal stakeholders and client business teams for customized solutionsManage project timelines and train junior team membersRequirements:Bachelor's/Master's degree in Life Sciences with...

  • Regulatory Specialist

    3 months ago


    Bengaluru, India Tag Full time

    REGULATORY SPECIALISTAt Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...


  • Bengaluru, India Brunel Full time

    We’re hiring Environmental / Regulatory Advisor for one of our Leading MNC in Oil & Gas to join their growing team. This position is based out in Bangalore/Chennai. **About this role** Position: Environmental / Regulatory Advisor; YOE: 10 Years; Contract: On Contract; Location: Bangalore. - The Environmental, Regulatory & Socioeconomic (ER&S) Advisor...

  • Regulatory Publisher

    5 months ago


    Bengaluru, India Indegene Full time

    Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most...


  • Bengaluru, India Philips Full time

    JOB DESCRIPTION Job Title Regulatory Affairs Manager Job Description Job Title : Regulatory Affairs Manager Position Summary: You are part of Philips Patient Care Informatics (PCI) Regulatory Affairs Organization. The Regulatory Affairs team comprises a group of enthusiastic professionals across the globe that work as a cohesive team to...


  • Bengaluru, Karnataka, India State Street Full time

    Job Title: Regulatory Reporting Department: Report Preparation Job Summary: We are seeking a talented Regulatory Reporting professional to join our team at State Street. As a Senior Associate, you will play a key role in supporting the FINREP & Branch Team in the preparation of daily, monthly, quarterly, and annual reporting to local...


  • Bengaluru, Karnataka, India Zebra Full time

    At Zebra, we are a community of innovators who strive to create new ways of working that make everyday life better.As a Regulatory Specialist within our worldwide Regulatory Department, you will be working closely with Government agencies, Test Labs, Industry Bodies, authorized representatives, and other partners to ensure an optimized process for securing...


  • Bengaluru, Karnataka, India Novo Nordisk Full time

    Regulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: RA Submission Systems Development**The position** - As a Regulatory Professional at Novo Nordisk, you will be responsible for a variety of tasks and responsibilities, including:- Providing support, maintenance, and gatekeeping and...

  • Regulatory Associate

    5 months ago


    Bengaluru, India Indegene Full time

    Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most...

  • Regulatory Reporting

    5 months ago


    Bengaluru, Karnataka, India Virtusa Full time

    Excellent communication skills, approachable and good at forming relationships with people of all levels within the business Excellent knowledge in financial market and financial products is a must Experience of working on systems and process engineering projects within Capital Markets domain Experience in Regulatory reporting (EMIR/MiFID/ESMA/DFA)...


  • Bengaluru, Karnataka, India Goldman Sachs Full time

    Job SummaryWe are seeking a highly skilled Operations professional to join our Regulatory Reporting team within Regulatory & Control Operations at Goldman Sachs.Key ResponsibilitiesDevelop in-depth knowledge of regulatory requirements, processes, and systems across global jurisdictions.Perform reconciliation and exception management in accordance with...