Lifelancer

Compliance

• Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
• Provide guidance to teams on the content, format, style and architecture of IND, or CTAs (ex-US studies).
• Perform/manage critical analysis of data (clinical, preclinical and manufacturing) independently develop interpretations and conclusions.
• Perform reviews of clinical protocols and study reports to focus attention of deficient/missing items/explanations.
• Accountable for ensuring the completeness and accuracy of all regulatory submissions
• Supervisory responsibility for planning, preparation and submission of regulatory documentation
• Management of the planning, preparation and submission of Investigational New Drug Applications (INDs) and Biologic Licensing Applications (BLAs)
• Provide guidance/instruction to teams on the content, format, style architecture and timing of BLAs
• Assist with scientific writing and review of a BLA and evaluate conformance with regulatory requirements
• Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing developmental programs

Senior Manager, Regulatory Affairs

Research Analyst

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
• Collaborating with investigators and site staff to facilitate smooth study conduct
• Performing data review and resolution of queries to maintain high-quality clinical data
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports

Clinical Research Associate

• Meet/greet clinical research volunteers and ensure their comfort during visits
• Check vitals (height, weight, blood pressure, BMI) and assess health per study protocol
• Perform phlebotomy on study subjects according to client protocols
• Ensure study participants are healthy enough to participate according to protocol
• Follow clients' protocols for vital sign assessments and phlebotomy procedures
• Participate in meetings and other assignments as part of a collaborative team
• Chaperone study subjects during breaks and provide personalized care to ensure comfort

Medical Research Associate

• All aspects of tasks related to prevention, detection, assurance & oversight of Regulatory reporting function.
• Manage back reporting functions for in scope trades within deadline in coordination with stakeholders
• Exception Monitoring & Control processes to be run and remediated ensuring trades related to technical fixes which are prioritised are remediated daily where possible, e.g. static updates.
• Timely responses to external & internal queries.
• Assist with building tactical and strategic processes and collaborate with Technology & Change teams to deliver strategic metrices.
• Ensure adherence to Process Documents including regular up-dation and execution of the same.
• Ensure robust control framework is enriched and followed by Regops team.
• Actively participate in group Projects/changes
• Practice robust controls on reporting to evidence completeness, accuracy & timeliness.
• Maintain consistency of processes & MI across regulatory regimes e.g. SFTR, MIFID & EMIR…etc
• Identify improvement to processes & drive delivery of change management.
• Collaboration across teams, regions & time zones to meet the responsibilities of the global team.
• Understand the system architecture limitations & remediation plans to ensure impact on day to day reporting can be mitigated.
• Evolve, improve & question processes and ensure timely escalations of issues.
• Display exemplary conduct and live by the Group’s Values and Code of Conduct.
• Take personal responsibility for embedding the highest standards of ethics, including regulatory and business conduct, across Standard Chartered Bank.
• Effectively and collaboratively identify, escalate, mitigate and resolve risk, conduct and compliance matters

Regulatory Operations Manager

Recruitment

• Take ownership and manage recruitment projects, encompassing gathering the requirements for the role, performing market research about best places to hire and how to structure the compensation & benefits, managing the different stakeholders, sourcing and presenting candidates, providing input based on your experience.
• Conduct regular job evaluations to ensure accurate job classifications and competitive salary ranges.
• Conduct data analysis and generate reports related to compensation and benefits to support management decision-making.
• Develop and implement competitive compensation strategies aligned with company goals and market trends.
• Maintain a consistent pay philosophy for all employees.
• Design and implement compensation structures tailored to different roles and seniority levels.
• Analyze market trends and benchmark salaries and benefits to ensure competitiveness.
• Calculate and propose salary packages, bonuses, and benefits based on multiple variables (e.g., location, experience, contract type).
• Advise on statutory compliance related to compensation (e.g., PF, ESI, gratuity, tax implications).
• Support the recruitment team by providing compensation insights and helping craft attractive offers.
• Collaborate with leadership to develop compensation strategies for freelancers, contractors, and full-time employees.
• Maintain up-to-date knowledge of labor laws and compensation regulations in India.

Recruitment Consultant

• Perform synthetic chemistry reactions, reaction workups, and purification of compounds using column chromatography, crystallization, re-crystallization, and preparative TLC
• Operate laboratory equipment and ensure samples generated during synthesis are submitted for analysis
• Record observations, results, resource utilization, and related activities in laboratory notebook or e-notebook following guidelines
• Update supervisor/group leader on synthesis progress and ensure samples are packed appropriately for shipment
• Meet Syngene productivity expectations (# compounds/month and # steps/month) without compromising safety and quality
• Synthesize final compounds with fast turnaround times and provide excellent analytical interpretation and purification
• Follow EHS and quality system requirements, know SDS and emergency procedures, and ensure proper waste segregation
• Attend mandatory trainings and maintain training records
• Ensure confidentiality of project information

Senior Research Associate

• Full ownership of investigator sites from study initiation to close-out
• Conducting feasibility, site selection, interim, and close-out visits
• Building strong relationships with investigator site staff to meet key clinical metrics
• Attending investigator meetings, ensuring proper shipment, storage, and accountability of clinical supplies
• Monitoring data integrity and compliance with clinical trial guidelines
• Dedicated to one global pharmaceutical client focused on oncology studies

Senior Clinical Research Associate

QA Engineer

• Manage GxP QA functions with an emphasis on Good Clinical Practice (GCP), compliance for both clinical and marketed products
• Partners with Clinical Development/Operations and actively participates on clinical study teams to ensure GCP compliance
• Assists in identifying and communicating clinical trial-related risks and opportunities for process improvement
• Reviews study related documents and plans
• Develops and executes PTC’s GxP risk-based study audit strategy to achieve compliance with applicable current regulatory requirements
• Performs internal and external audits to assure compliance with GCP regulations and guidelines (may include internal processes, regulatory filings, Clinical Research Organizations (CROs), investigator sites, and other vendors)
• Communicates audit results to internal stakeholders and writes audit reports
• Assesses audit responses and ensures closure of corrective action preventative actions (CAPAs)
• Performs GxP inspection readiness activities
• Leads front/backroom activities during regulatory authority inspections
• Advances PTC’s understanding of worldwide regulations, guidelines and GxP practices and assists in helping to meet regulatory compliance and corporate business requirements
• Manages, coaches and mentors direct reports
• Performs other tasks and assignments as needed and specified by management