Do you want to work in an environment and culture where you can thrive, develop and advance?
A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognize our people by providing valuable benefits and a quality of life balance.
An opportunity has arisen for a Senior Consultant (CMC Regulatory Affairs) to be based in Gurgaon or Bangalore.
2. Problem Solving and Analysis
- Project Delivery
As applicable, author and review non-clinical packages for submission to Health Authorities.
- Manages non-clinical project deliverables and submission content in line with project plan
- Proactively identifies moderately complex issues and risks to project delivery in own work or work of the team and escalates appropriately with associated resolution proposals
- Undertakes project specific activities independently and within cost and time estimates
- Responsible for process implementation and ensure process compliance .
- May support the Manager or Senior Manager in delivery and/or the successful initiation, execution and completion of non-clinical regulatory services for Kinapse’ Global clients
- May be responsible for reviewing submission output from team members.
- May assist in work allocation, compilation, tracking and reporting of the project reports on timely basis
- Applies negotiation skills to recommend time lines and change in requirements
- As applicable, author non clinical regulatory documents which meet agreed quality standard as agreed with client within stipulated time and cost.
- Should be acquainted with detail of various regulatory agency’s non-clinical safety requirements and GLP/GXP regulations.
- As applicable, author and review the protocols and study reports as well as other essential documents required in non-clinical studies.
3. People Development
- Exhibits a growing awareness of project strategy and thinking capability alongside independence
- Reviews and provides solutions for issues relating to project delivery or escalates appropriately to the Team Leader/Program Leader/Program Director as required
- May be involved in people development in partnership with PDG leads
- Provide training and mentoring of team members depending upon the project requirement
4. Training Compliance
- Ensure that all training (Kinapse internal training and client training) are successfully completed in a timely manner
- Post Graduate with Masters in Pharmacy or D/ Post Graduate degree in Life Sciences
- Experience in non-clinical regulatory affairs with exposure to regulatory filings as a part of a pharmaceutical or generic company are preferred
- Understanding of toxicological studies required to support clinical trials including genetic and general toxicology studies and nomenclature
- Knowledge of non-clinical regulatory requirements and/or guidelines (ICH, GCP) and exposure to relevant document management systems are preferred.
- Good oral / written communication skills
- Working knowledge of basic office applications, e.g. MS Word/ PowerPoint/ Excel, will be required.
We believe that Diversity & Inclusion are central to a dynamic, exciting and innovative organization. To review our D&I policy please visit https://kinapse.com/diversity-inclusion