Business Analyst (Life Sciences Regulatory affairs)

TechDigital Group; New York (NY); Hybrid; USD 110,000 - 150,000; Full time

Job summary

TechDigital Group in New York is seeking an experienced Business Analyst with Life Sciences and Regulatory Affairs domain knowledge to gather business requirements, analyze regulatory processes, and support regulatory technology and compliance initiatives.

The role collaborates with Regulatory Affairs, Quality, IT, and business stakeholders, covers BRDs/FRDs, user stories and process workflows, and leverages Agile, UAT, and regulatory platforms such as Veeva Vault RIM and OpenText to drive

Qualifications

• Strong experience in Life Sciences, Pharmaceutical, and Regulatory Affairs.
• Expertise in regulatory submissions, documentation, and compliance processes.
• Knowledge of FDA, EMA, ICH guidelines, and global regulatory requirements.
• Experience with RIM (Regulatory Information Management) systems and regulatory data management.
• Understanding of eCTD submissions, submission publishing, and regulatory lifecycle management.
• Experience gathering requirements, creating BRDs, FRDs, user stories, and process workflows.
• Collaborate with Regulatory Affairs, Quality, IT, and business stakeholders.
• Experience with Agile methodologies, UAT, gap analysis, and process improvement.
• Knowledge of Veeva Vault RIM, OpenText, and regulatory technology platforms.
• Preferred: Experience with Veeva Vault RIM, IDMP standards, SPL, eCTD 4.0, and regulatory process digital transformation.

Responsibilities

• Gather business requirements, analyze regulatory processes, and support regulatory technology and compliance initiatives.
• Collaborate with Regulatory Affairs, Quality, IT, and business stakeholders.
• Gather requirements, create BRDs, FRDs, user stories, and process workflows.
• Apply Agile methodologies, UAT, gap analysis, and process improvements.

Skills

Life Sciences

Regulatory Affairs

Regulatory submissions

Documentation

Compliance processes

FDA/EMA/ICH guidelines

Regulatory data management

BRDs/FRDs

User stories

Process workflows

Agile methodologies

UAT

Gap analysis

Regulatory technology platforms

Tools

RIM systems

Veeva Vault RIM

OpenText

Job description

Job Description

Seeking an experienced Business Analyst with strong Life Sciences and Regulatory Affairs domain knowledge to gather business requirements, analyze regulatory processes, and support regulatory technology and compliance initiatives.

Key Responsibilities & Skills

• Strong experience in Life Sciences, Pharmaceutical, and Regulatory Affairs.

• Expertise in regulatory submissions, documentation, and compliance processes.

• Knowledge of FDA, EMA, ICH guidelines, and global regulatory requirements.

• Experience with RIM (Regulatory Information Management) systems and regulatory data management.

• Understanding of eCTD submissions, submission publishing, and regulatory lifecycle management.

• Experience gathering requirements, creating BRDs, FRDs, user stories, and process workflows.

• Collaborate with Regulatory Affairs, Quality, IT, and business stakeholders.

• Experience with Agile methodologies, UAT, gap analysis, and process improvement.

• Knowledge of Veeva Vault RIM, OpenText, and regulatory technology platforms.

Preferred: Experience with Veeva Vault RIM, IDMP standards, SPL, eCTD 4.0, and regulatory process digital transformation.