Regulatory Affairs Manager

Role Overview: The Regulatory Affairs Manager will be responsible for managing the regulatory submissions process, maintaining compliance with regulatory requirements, and liaising with regulatory authorities. This role requires a deep understanding of the pharmaceutical regulatory landscape and excellent communication skills to navigate complex regulations.

Key Responsibilities:

1. Regulatory Strategy Development:
   • Develop and implement regulatory strategies for new products and product changes in alignment with corporate goals.
   • Advise internal teams on regulatory requirements and best practices.
2. Submission Management:
   • Prepare, review, and submit regulatory documents, including INDs, NDAs, BLAs, and annual reports.
   • Ensure timely and accurate submissions to regulatory agencies.
3. Compliance Monitoring:
   • Monitor compliance with FDA, EMA, and other global regulatory requirements throughout the product lifecycle.
   • Conduct audits and inspections to ensure adherence to regulatory standards.
4. Liaison with Regulatory Authorities:
   • Serve as the primary contact with regulatory agencies, responding to inquiries and facilitating communication.
   • Represent the company in meetings with regulatory authorities and during inspections.
5. Cross-Functional Collaboration:
   • Work closely with R&D, Quality Assurance, and Marketing teams to ensure regulatory compliance in product development and promotional activities.
   • Provide regulatory guidance on product labeling, advertising, and marketing materials.
6. Risk Assessment:
   • Assess potential regulatory risks and develop strategies to mitigate them.
   • Keep abreast of changes in regulations and industry trends, advising management accordingly.
7. Training and Development:
   • Train and mentor junior staff on regulatory affairs processes and compliance requirements.
   • Develop and maintain standard operating procedures related to regulatory submissions.

Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree preferred.
• 5+ years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of global regulatory requirements and submission processes.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication abilities.
• Ability to work collaboratively in a cross-functional team environment.
• Proficiency in regulatory submission software and MS Office Suite.

Why Join Us?

• Contribute to meaningful work in the pharmaceutical industry focused on improving patient health.
• Competitive salary and comprehensive benefits package.
• Opportunities for professional growth and career advancement.
• Supportive work environment that values innovation and teamwork.