Sr.Executive/AM -RA (Derma & Nasal)

Job Description:

We are seeking a highly skilled Regulatory Affairs Senior Executive and Assistant manager with experience in the US market for derma and nasal products. The ideal candidate should have expertise in CMC Module 3 submissions and a deep understanding of regulatory requirements.

Responsibilities:

• Lead the regulatory affairs team in developing and implementing regulatory strategies for product submissions in the US market.
• Prepare and review CMC Module 3 documentation for derma and nasal products.
• Ensure compliance with FDA regulations and guidelines.
• Collaborate with cross-functional teams to support product development and registration activities.
• Stay up-to-date with changing regulations and guidelines in the pharmaceutical industry.

Qualifications:

• Bachelor's degree in a relevant field, such as Pharmacy, Chemistry, or Life Sciences.
• Minimum of 5 years of experience in regulatory affairs, with a focus on derma and nasal products for the US market.
• Strong knowledge of CMC Module 3 requirements and submission processes.
• Excellent communication and interpersonal skills.
• Attention to detail and ability to work in a fast-paced environment.

Skills:

• Regulatory Compliance
• CMC Module 3 Expertise
• FDA Regulations
• Quality Assurance