PSI CRO Looking for Regulatory Affairs Assistant at Bengaluru, Karnataka Full Time

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the 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 frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Join our international team and support regulatory aspects of clinical research projects in India, streamlining communication, maintaining electronic systems and managing documents.

Office-based in Bangalore, India

You will:
Be the point of contact for clinical project teams and support services on regulatory matters

Prepare draft regulatory/ethics submission dossier

Be responsible for document management such as filing, processing, translation, quality control

Update and maintain (automated) tracking systems, working files, and schedules

Organize meetings, prepare agendas and minutes

Qualifications

College/University degree or an equivalent combination of education, training & experience

Life Science degree is a plus

Prior administrative experience in Clinical research, preferably in Clinical Operations, Startup, Regulatory Affairs or Pharmacovigilance

Full working proficiency in English

Proficiency in MS Office applications

Ability to plan, multitask and work in a dynamic team environment

Communication and collaboration 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.