Responsibilities:
Dossier Preparation:
- 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.
DMF Management:
- 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.
Compliance Oversight:
- 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.
Qualifications:
Education:
- Bachelor’s 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.
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Proven track record of successful dossier preparation and submission.
Key Skills:
- 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.
What We Are Looking For:
- 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.
Join our team and be a vital part of ensuring regulatory excellence in the pharmaceutical industry!
