Regulatory Affairs Manager at Sigma Consult

Role Summary:

As a Regulatory Affairs Manager, you will oversee all regulatory compliance activities related to the development, registration, and marketing of pharmaceutical products. You will ensure that the company complies with all applicable regulations and guidelines to maintain product quality and safety.

Responsibilities:

• Develop and implement regulatory strategies for product registration and approval.
• Prepare and submit regulatory submissions to regulatory authorities, including new drug applications, variations, and renewals.
• Review product labeling and promotional materials to ensure compliance with regulatory requirements.
• Monitor changes in regulations and guidelines and communicate relevant updates to stakeholders.
• Represent the company in interactions with regulatory authorities and industry organizations.

Requirements:

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• Proven experience in regulatory affairs in the pharmaceutical industry.
• Strong knowledge of pharmaceutical regulations and guidelines.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Attention to detail and ability to manage multiple projects simultaneously.

Benefits:

• Competitive salary package.
• Opportunities for professional development and career advancement.
• Access to state-of-the-art facilities and resources.
• Supportive work environment fostering collaboration and innovation.
• Comprehensive benefits package including health insurance and retirement benefits.