Regulatory Affairs

Responsibilities:

Dossier Preparation:

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

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

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• Stay abreast of regulatory changes and updates, ensuring the organization's compliance with industry standards.
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• Conduct internal audits to assess compliance with regulatory requirements.
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• Develop and implement strategies to address and rectify compliance issues.
  
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Qualifications:

Education:

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or a related field.

Experience:

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

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

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