A Regulatory Senior Associate will play an important role in executing Regulatory projects for Kinapse's global clients. Regulatory Associate will work as part of high-performing teams of typically 3-8 people on challenging assignments involving the processing of regulatory information. Regulatory Associates will report to a Regulatory Manager/ Scientist for their day-to-day project work.

Regulatory activities will be undertaken according to defined processes and operating procedures, which will be subject to internal and external audit.

Responsibilities:

Under supervision and with guidance from more senior service line colleagues:

• Undertake project specific activities with extremely high reliability at high quality and in tight timelines within cost and time estimates according to standard processes and operating procedures, preparation of components for generating submission ready dossiers such as market accessions, variation dossiers, renewal dossiers, annual reports etc.
• Preparation of records and/or logs and maintenance/update of regulatory databases as per Kinapse and/or client requirements

• QC checks of output generated in the project and follow up till final submission or delivery to client.
• Identification of risks to project delivery related to own workload and appropriate escalation
• Ensure that all training (Kinapse internal training and client training) are successfully completed in a timely manner

We are looking for a candidate with the following competencies:

• Educational qualifications - Authors:
  • A minimum of a Post graduate degree from a well-known institution
  • Candidates will have any one of the following qualifications from a reputed university:
    • Masters in Pharmacy (preferably Pharmaceutics, QA, Industrial Pharmacy)
    • Ph.D or Post Graduate degree in Life Sciences
• Educational qualifications - Publishers:
  • A minimum of a graduate degree from a well-known institution
• Candidates with experience in Regulatory affairs, with exposure to regulatory filings, as a part of a pharmaceutical company are preferred
• Significant knowledge of regulatory requirements and/or guidelines is preferred
• Knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc.
• An ability to create clear, concise written and oral communications
• Working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel
• Core competencies for this role include:
  • Effective management of individual workload
  • Analytical capabilities, familiarity and comfort with regulatory concepts
  • Professional service mentality - willing to go beyond the call of duty to satisfy their clients
  • Commitment to highest quality outputs, including meticulous attention to detail
  • Enthusiasm and pro-activity
• Team collaborator, ability to be successful working in teams