Job Description (JD):

Define regulatory strategy across global regions for NCEs, generics, or biosimilars.

Liaise with global agencies (FDA, EMA, TGA, MHRA) for approvals.

Oversee preparation and review of global dossiers.

Provide regulatory intelligence and risk assessment inputs during product development.

Required Skills:
Global submission experience, in-depth regulatory knowledge, cross-functional leadership.

Manages the development and review of clinical study protocols. Ensures protocols are scientifically sound and comply with regulatory guidelines.

Coordinates with research teams to integrate feedback and updates.

Job Description (JD):

Prepare technical files such as Product Dossiers, DMFs, and stability data.

Ensure regulatory documents meet global requirements.

Maintain compliance records and version control for documents.

Required Skills:
Attention to detail, knowledge of CTD/eCTD format, and basic regulatory processes.

Assist in the preparation and submission of dossiers (CTD/eCTD format) to regulatory authorities (CDSCO, USFDA, EMA, etc.).

Maintain regulatory documentation and track submission timelines.

Support in label, artwork, and packaging compliance review.

Coordinate with QA, QC, and R&D for product data collection.

Monitor post-approval changes and renewals.

Required Skills:
B.Pharm / M.Pharm / M.Sc. in Life Sciences, strong documentation & MS Office skills, good understanding of regulatory guidelines.

Assist in the preparation and submission of dossiers (CTD/eCTD format) to regulatory authorities (CDSCO, USFDA, EMA, etc.).

Maintain regulatory documentation and track submission timelines.

Support in label, artwork, and packaging compliance review.

Coordinate with QA, QC, and R&D for product data collection.

Monitor post-approval changes and renewals.

Required Skills:
B.Pharm / M.Pharm / M.Sc. in Life Sciences, strong documentation & MS Office skills, good understanding of regulatory guidelines.

Are you ready to elevate your clinical research career with one of the worlds most innovative healthcare leaders Novartis is looking for a passionate and experienced Senior Clinical Research Associate to join our dynamic and mission-driven team.

What Youll Do:
1. Lead and monitor clinical trial sites across phases ensuring protocol integrity
2. Perform site selection, initiation, monitoring, and close-out visits
3. Ensure adherence to ICH-GCP, regulatory requirements, and study timelines
4. Collaborate with cross-functional teams to resolve site issues.

About the Role
Accentures Life Sciences team is expanding, and were looking for a Senior Drug Safety Physician who brings clinical expertise, scientific curiosity, and a passion for patient safety. If you thrive in a fast-paced, global environment and want to contribute to safer medicines worldwidethis is your opportunity.

What Youll Do
As a Senior Drug Safety Physician, you will be the medical expert at the heart of safety evaluation. Your responsibilities include:

Medical Review & Assessment Perform high-quality medical evaluation of adverse event cases (ICSRs), aggregate reports, and safety signals.
Benefit-Risk Analysis Provide scientific input to ensure patient safety and regulatory compliance.
Safety Strategy & Oversight Collaborate with cross-functional teams to drive safety strategies across global programs.
Regulatory Excellence Support PSURs, DSURs, RMPs, and other regulatory deliverables with medical expertise.
Leadership & Mentoring Guide safety teams, review work quality, and provide medical training where needed.
Stakeholder Collaboration Interact with global clients, internal teams, and regulatory counterparts to ensure alignment on safety decisions.

What Were Looking For
We're searching for someone who combines clinical acumen with strategic thinking:
Must-Have Skills:
MBBS / MD (Pharmacology, Internal Medicine, or related fields preferred).
48+ years of experience in Pharmacovigilance / Drug Safety.
Strong clinical judgement and understanding of drug development & safety regulations.
.
Why Join Accenture
At Accenture, youll work with world-leading pharma clients, cutting-edge technology, and a global team of medical and safety experts all while driving meaningful impact in patient care.
Innovation-driven culture
Opportunities for global exposure
Growth pathways into Safety Leadership roles
Hybrid work options
Learning & Certification support.

Cipla is looking for a highly motivated Drug Safety Physician to join our growing Pharmacovigilance team in Mumbai!

Key Responsibilities:
Medical review and assessment of adverse event reports
Signal detection, risk evaluation, and safety data analysis
Preparation of safety narratives, aggregate reports, and regulatory documents
Collaboration with cross-functional teams to maintain high-quality PV compliance
Ensuring alignment with global safety regulations and internal SOPs

Requirements:
MBBS / MD (Pharmacology or related specialization preferred)
26 years of experience in Pharmacovigilance / Drug Safety
Strong understanding of regulatory guidelines (ICH, MedDRA, GVP)
Excellent analytical and medical writing skills
Ability to work in a fast-paced, collaborative environment

JOB SUMMARY

This position is responsible for assisting in all clinical data management activities required for complex
clinical trials with high proficiency and by providing guidance to other Clinical Data Associates (CDAs).

JOB RESPONSIBILITIES

Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager and/or Biometrics Project Manager as necessary.
Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
Creates and enters test data for User Acceptance Testing (UAT)
Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices.
Receives and enters lab normal ranges.
Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.
Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the Data Validation Specification and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and requires where appropriate.
For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. Submits copies of the DCFs to sponsors as necessary.

Are you an experienced Clinical Data Management (CDM) professional with a passion for leading teams and empowering others through training APCER Life Sciences is looking for a dynamic Clinical Data Management Lead & Training Specialist to join our growing Hyderabad team.

Key Responsibilities
Lead end-to-end Clinical Data Management activities across multiple global clinical trials.
Oversee data validation, query management, database setup, and database lock processes.
Develop, plan, and execute CDM training programs for new and existing team members.
Ensure compliance with global regulatory standards and company SOPs.


Requirements
Bachelors or Masters degree in Life Sciences, Pharmacy, or related field.
610+ years of experience in Clinical Data Management.
Prior experience leading CDM teams or training programs.
Strong knowledge of CDISC standards, EDC tools (Medidata Rave, Inform, etc.), and GCP guidelines.
Excellent communication, leadership, and analytical skills.