Regrow Biosciences is a sponsor company doing various stem cell and cell based therapy products clinical trials for life threatening diseases. This role will be an opportunity to learn and provide growth arena. Here the resource will be involved in handling regulatory meetings and communications.
- License Approval, Audit handling, Product presentation for doctors.
- Regulatory and Ethics committee meetings
- Funding Activities from the government agencies for clinical trials.
- Performs Initiation, Monitoring and Close-out activities in co-ordination with the project manager.
- Site Feasibility, Budget negotiation and Study start-up activities.
- To prepare site visit reports.
- Coordinating between sponsors, investigators and CRO
- IP Management and accountability
- Evaluate the speed of recruitment and propose alternative solutions if the predefined objectives are not met
- Provide oversight of all study-related activities
- Animal clinical trials, human clinical trials, Regulatory Affairs, Pharmacovigilance.
- Resolve issues as they affect clinical plan timelines and quality to ensure achievement of goals and objectives at site level.
- Responsible for monitoring the progress of all projects to include quality of services provided timelines of deliverables and compliance with regulatory requirements.
- To liaise with other departments within the organization for timely achievement of the project milestones.
- Provide in-house project support to project team members for all the trial related activities.
- Communicate with central laboratory for logistics/shipment from investigator sites
- To ensure all assigned studies follow organizational/ applicable SOPs, GCP and local regulations
- Co-ordinate in Ethics committee submission.
- Assist in preparation and submission of regulatory documents. Maintain and update study specific trackers.
Preferred- Should have thorough knowledge of Indian FDA System esp. the Drugs and cosmetics Act and all CDSCO related.
Desired Candidate Profile
Good communication Skills in Hindi and English.
Salary: Not Disclosed by Recruiter
Role:Clinical Research Associate/Scientist
Desired Candidate Profile
PG:M.Pharma - Pharmacy
Regrow Biosciences Private Limited
Regrow Biosciences Pvt Ltd
You Grow. We Grow. Regrow
Driven by passion, strong business ethics and commitment, Regrow Biosciences Pvt Ltd was established with a Vision to become the world's largest stem cell based tissue and organ development factory. Today, Regrow is India’s leading biotech company pioneering in the field of regenerative medicine having built a platform technology for cell based products.
Regrow Biosciences is World’s 1st company to have three commercialised cell therapy products.
Ossgrow® is 1st Bone Cell Therapy in world
Cartigrow® is 1st Cartilage Cell Therapy in India
Uregrow® is 1st Epithelial Cell Therapy in world
Regrow Biosciences has also been immensely successful in establishing premium cord blood stem cell bank; Biocell® (formerly known as Babycell™) with patronage of more than 51000 happy parents.
Our Mission remains focused to improving human healthcare by innovating and delivering regenerative medicine based solutions.
Globally located in Singapore (Asia) and Texas (United States), Regrow Biosciences has paved the way on world’s map and steadily progressing towards our mission and towards improving lifestyle of global community.
- Strong Pillars
Our story began in 2009, when the experience of CEO Mr. Yash Sanghavi, Promoter of Satyan Pharmaceuticals Pvt Ltd (estd 1984) and the passion of his son, Mr. Satyen Sanghavi (Post Graduate Stem Cell Technology from University of Nottingham, UK) combined to result in creation of “Regrow”.
Regrow’s RnD & GMP certified facility was set up in Lonavala (Pune) & now operates with a team of more than 30 stem cells scientist.
Regrow is continually cultivating an ecosystem by developing relationship with stakeholders including patients, physicians, hospitals & supply chain partners to deliver quality products targeted for diseases with unmet need.
Educating the society about the benefits of “Cure vs Manage” through use of the most advanced & cutting edge medical treatments using cell therapy.
Contributing to nation building by aligning the corporate strategy to Make In India.
- Dream Big
Aspiring to lead the cell & gene therapy sector, Regrow has successfully established technological prowess on the global platform by receiving the recognition from USFDA (United States) & EMA (Europe) for its products.
Life at Regrow®
- At Regrow, we believe in creating opportunities to learn and develop. Support our employees’ passions so they will be more engaged and motivated at work and life in general.
- Rewards and recognitions come hand in hand with fast track growth program
- For more than a decade, our team have thrived on dynamic and challenging career opportunities across all areas of the organization.
- 60% of our new recruits join us during their early stages of their careers
- The average tenure of our employees is more than 5 years
- We believe in providing equal opportunities to all. Our team consist of 40% women and major portfolios are being successfully handled by females.
- Work life balance is at top priority. Flexibility in work hrs and work from home option, paid leaves worth a month, daily and monthly team events help in keeping us charged up
- We are closely knit Regrow Family connected by passion towards creating healthy lifestyles globally and willing to welcome new members wholeheartedly!
Contact Company:Regrow Biosciences Private Limited
Address:2ABC,2ND FLOOR,ACME PLAZA,ANDHERI KURLA ROAD,ANDHE, RI-EAST, , MUMBAI, Maharashtra, India