RA (Derma & Nasal)
Share
Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
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
