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Life Science Regulatory Services New Associate

0-1 years
Not Disclosed
10 April 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Job description


Skill required: Regulatory Services - Life Sciences Regulatory Operations

Designation: LifeScience Regulatory Svs New Associate

Qualifications:Any Graduation

Years of Experience:0 to 1 years
Language - Ability:English - Intermediate

What would you do?
You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.You will be expected to coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc.

What are we looking for?

  • Roles and Responsibilities:
  • In this role you are required to solve routine problems, largely through precedent and referral to general guidelines
  • Your primary interaction is within your own team and your direct supervisor
  • In this role you will be given detailed instructions on all tasks
  • The decisions that you make impact your own work and are closely supervised
  • You will be an individual contributor as a part of a team with a predetermined, narrow scope of work
  • Please note that this role may require you to work in rotational shiftsQualificationAny Graduation

Role: Non Tech Support - Voice / Blended

Industry Type: IT Services & Consulting

Department: Customer Success, Service & Operations

Employment Type: Full Time, Permanent

Role Category: Voice / Blended

Education

UG: Any Graduate

PG: Any Postgraduate