Associate- Drug Regulatory Affairs us

4 days ago

Gurugram Haryana, India DDReg Pharma Full time

DDReg Pharma
DDReg Pharma
Full Time
Gurgaon
Posted 4 hours ago
**Job Purpose**:
**Key Responsibilities**:Regulatory Compliance**:
Strong understanding of U.S. regulatory requirements, particularly FDA guidelines, and will be responsible for preparing and submitting regulatory documentation for ANDA, maintaining compliance records, and liaising with regulatory agencies. Knowledge about post approval activities is an added advantage.
**eCTD/CTD Sequence Review**:
Maintain up-to-date knowledge of eCTD requirements and review of the sequence to ensure submission quality and compliance with regulatory standards.
**Query Handling & Documentation**:
Draft and review regulatory authority responses. Ensure clarity, regulatory alignment, and timely submission.
**Functional File Preparation**:
Handle electronic publishing tasks including hyperlinking, bookmarking, redactions, and formatting. Ensure technical accuracy and reduce rework.
**Artwork & Labeling Review**:
Prepare and review artworks and comparative labeling texts. Ensure accuracy, consistency, and regulatory compliance.
**Project Tracking & Documentation**:
Maintain trackers, task planners, product history logs, and query records. Participate in client meetings and contribute to regulatory planning and decision-making.
**Team Collaboration & Communication**:
Collaborate with internal stakeholders and external clients. Ensure timely follow-ups, documentation clarity, and professional engagement.
**Educational Qualifications**:
B Pharm/ M Pharm
**Soft Skills**:
Strong communication and interpersonal skills
Time management and multitasking
Analytical thinking and collaboration
Positive, adaptable attitude
Related Blog Post
Job Features
Job Category
Regulatory Affairs

  • Associate - Regulatory Affairs

    18 hours ago

    Gurugram, Haryana, India DDReg Pharma Full time

    -Full Time Gurgaon Posted 5 days ago Job title Associate - Regulatory Affairs - Reports to Senior Associate/Astt Manager/Manager - Regulatory Affairs - **Job purpose**: To carry out Regulatory Review and Compilation of Technical documentation & dossiers for - Various Markets in compliance to applicable regulations and guidelines. - **Duties and...

  • ▷ [Urgent] Regulatory Affairs Specialist

    3 weeks ago

    Gurugram, India Respironics Inc Full time

    Job Description Job Title Regulatory Affairs Specialist Job Description Job title: Regulatory Affairs Specialist Your role: Regulatory Affairs Specialist - ISC will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs Team and help business with product registration in the India Sub Continent, actively providing value-added...

  • Regulatory Affairs

    18 hours ago

    Gurugram, Haryana, India Ethics Group Of Companies Full time

    **Responsibilities**: - **Regulatory Compliance**: - Stay abreast of current and evolving regulations related to Drug License and FSSAI requirements. - Ensure the organization's adherence to all applicable government regulations and standards. - **Drug License Application**: - Coordinate with regulatory authorities for timely approvals and compliance...

  • Assistant Manager- Regulatory Affairs

    5 days ago

    Gurgaon, Haryana, India Johnson & Johnson Full time

    At Johnson Johnson we believe health is everything Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full...

  • Country Regulatory Affairs Manager

    1 week ago

    Gurugram, India Glanbia Full time

    We are seeking a highly experienced and detail-oriented Regulatory Affairs professional to manage regulatory compliance for our Sports Nutrition portfolio across India and international markets. This individual contributor role involves reviewing product formulations, labels, and claims, ensuring alignment with FSSAI and global regulatory frameworks, and...

  • Senior Regulatory Specialist

    5 days ago

    haryana, India SUN PHARMA Full time

    We're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility 1. New submissions:a. Review & prepare CMC...

  • Senior Regulatory Specialist

    5 days ago

    Gurugram, India SUN PHARMA Full time

    We're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility 1. New submissions:a. Review & prepare CMC...

  • Senior Regulatory Specialist

    5 days ago

    Gurugram, India SUN PHARMA Full time

    We're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility 1. New submissions:a. Review & prepare CMC...

  • Senior Regulatory Specialist

    5 days ago

    Gurugram, India SUN PHARMA Full time

    We're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility 1. New submissions:a. Review & prepare CMC...

  • Senior Regulatory Specialist

    5 days ago

    Gurugram, India SUN PHARMA Full time

    We're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon. Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC...