Regulatory Affairs

Lendex Technology; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

A pharmaceutical company based in Gujarat is seeking a Regulatory Affairs Specialist to manage Drug Master Files and ensure compliance with industry regulations. The ideal candidate will have a Bachelor's degree in Pharmacy or related field, along with 4-7 years of experience in the pharmaceutical industry. Responsibilities include preparing regulatory documentation, conducting audits, and staying updated on regulatory changes. Excellent organizational and communication skills are crucial for success in this role.

Qualifications

• 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.

Responsibilities

• Compile and prepare regulatory documentation ensuring accuracy.
• Manage Drug Master Files (DMFs) and ensure timely submissions.
• Stay abreast of regulatory changes and assess compliance.

Skills

In-depth knowledge of Drug Master Files (DMFs)

Strong understanding of compliance principles

Excellent analytical and problem-solving skills

Attention to detail

Effective communication and interpersonal skills

Education

Bachelor’s degree in Pharmacy, Chemistry, Life Sciences

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 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!