Regulatory Affairs

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 organization's 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:

• 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.
• 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!