Manager/ Sr. Manager - Regulatory Affairs

2+ years

Not Disclosed

Ahmedabad

10 Aug. 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Organizational Overview

Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad, India. We operate with facilities in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA), and Fargo (USA), employing over 1,500 staff worldwide.

With over 20 years of experience in providing full-spectrum clinical trial solutions, Lambda Therapeutic Research offers comprehensive services to the biopharmaceutical and generic industries. Our team of highly qualified and experienced industry leaders applies innovative technologies and therapeutic expertise, driven by a commitment to quality, to help clients develop products safely, effectively, and swiftly.

At Lambda, our employees are the cornerstone of our quality promise. We are dedicated to hiring qualified and energetic individuals who strive for excellence to join our team.

Job Details

Job Role: Manager/Sr. Manager - Regulatory Affairs
Reporting To: Head of Department/Project Head
Department: Regulatory Affairs
Location: Ahmedabad
Overall Purpose: Coordinate and support the submission of dossiers to the DGCI and other regulatory bodies.

Key Deliverables:

Lead and manage the regulatory affairs team.
Oversee regulatory functions, including submission of dossiers to DCGI, Zonal office, and other regulatory bodies for BE NOC, CT NOC, T-license, etc., via SUGAM and NSWS portals.
Follow up with CDSCO officials to expedite application processing and obtain approvals.
Lead discussions with DCGI/CDSCO officials on technical queries.
Report Serious Adverse Events (SAEs) on SUGAM and NSWS portals.
Provide technical guidance for preparing and submitting responses to DCGI queries.
Notify regulatory bodies about approved documents.
Provide feasibility inputs for upcoming projects from a regulatory perspective.
Conduct literature searches for product submissions and maintain knowledge of regulatory status.
Maintain a daily tracker for submitted applications.
Review and upload regulatory, DCGI, and Ethics Committee (EC) documents to the eTMF software.
Submit study information on the CTRI site for registration.
Prepare applications for CBN submissions for narcotic and psychotropic products.

Allied Responsibilities:

Perform additional tasks as assigned by the Head of the Department or Project Head.

Experience:

Minimum of 2 years of experience in regulatory affairs.

Educational Qualification:

Bachelor’s or Master’s degree in Pharmacy.

Competencies:

Accountability: Taking ownership of tasks and responsibilities.
Communication: Effective verbal and written communication skills.
Work Ethic: Demonstrates reliability and dedication.
Initiative: Proactively addressing challenges and seeking improvements.
Leadership: Ability to lead and guide team members.
Technical Knowledge: Expertise in regulatory affairs and submission processes.
Motivation/Initiative: Drive to achieve results and improve processes.
Interpersonal/Leadership Skills: Ability to build relationships and lead teams.
Presentation/Communication Skills: Skill in presenting and communicating information.
Organizational Culture Fit: Alignment with company values and culture.
Flexibility/Planning & Organizing: Adaptability and effective management of tasks.

Accomplishments & Strengths:

Proven achievements in managing regulatory affairs and submission processes.
Effective communication and coordination with regulatory bodies.

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Manager/ Sr. Manager - Regulatory Affairs

Job Description

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