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Regulatory Affairs
Regulatory AffairsLendex Technology • Ahmedabad, Gujarat, India
Regulatory Affairs

Regulatory Affairs

Lendex Technology • Ahmedabad, Gujarat, India
11 hours ago
Job description

Responsibilities :

Dossier Preparation :

  • Compile review and prepare regulatory documentation ensuring accuracy and completeness.
  • Collaborate with cross-functional teams to gather necessary information for dossier submissions.
  • Maintain and update regulatory files and databases.

DMF Management :

  • Manage Drug Master Files (DMFs) and ensure timely submissions to regulatory authorities.
  • Liaise with internal teams and external partners to obtain required information for DMF updates.
  • Monitor DMF compliance and address any deficiencies in collaboration with relevant stakeholders.

    • Compliance Oversight :

  • Stay abreast of regulatory changes and updates ensuring the organizations compliance with industry standards.
  • Conduct internal audits to assess compliance with regulatory requirements.
  • Develop and implement strategies to address and rectify compliance issues.

    • Qualifications : Education :

  • Bachelors degree in Pharmacy Chemistry Life Sciences or a related field.

    • Experience :

  • Minimum of 4-7 years of experience in regulatory affairs within the pharmaceutical or related industry.
  • Proven track record of successful dossier preparation and submission.

    • Key Skills :

  • In-depth knowledge of Drug Master Files (DMFs) and regulatory requirements.
  • Strong understanding of compliance principles and practices.
  • Excellent analytical and problem-solving skills.
  • Attention to detail and ability to manage multiple tasks simultaneously.
  • Effective communication and interpersonal skills for collaboration with internal and external stakeholders.

    • What We Are Looking For :

  • A candidate with a keen understanding of regulatory affairs and the ability to navigate complex regulatory landscapes.
  • Someone who can take ownership of DMF filing management and demonstrate a proactive approach to compliance.
  • Strong organizational skills and attention to detail are crucial for success in this role.
  • The ideal candidate should be a team player with excellent communication skills capable of fostering collaboration across departments.
  • Ability to adapt to changes in regulatory requirements and implement strategies to ensure ongoing compliance.

    • Join our team and be a vital part of ensuring regulatory excellence in the pharmaceutical industry!

    Key Skills

    Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

    Employment Type : FULL_TIME

    Experience : years

    Vacancy : 1

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    Regulatory • Ahmedabad, Gujarat, India

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