Regulatory Affairs Specialist

If you are a highly motivated and detail-oriented individual with a passion for regulatory affairs, we invite you to apply for this exciting opportunity.

Position Title: Regulatory Affairs Specialist

Job Location: Donetsk, Ukraine

Position Type: Full-time

Salary: Competitive

Company: Pharma Advance Cooperation

Overview: We are seeking a highly skilled Regulatory Affairs Specialist to join our dynamic team. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with all applicable laws, regulations, and standards related to our company's products. You will be responsible for overseeing the entire regulatory process, from product development to post-market surveillance. The ideal candidate will have a strong understanding of regulatory requirements and be able to effectively communicate with both internal and external stakeholders. If you are passionate about regulatory affairs and have a keen eye for detail, we invite you to apply for this exciting opportunity.

Key Responsibilities:

• Conduct thorough research and stay up-to-date on all relevant laws, regulations, and standards related to our company's products
• Develop and implement regulatory strategies for new and existing products
• Prepare and submit all necessary product registration documents to regulatory agencies
• Serve as the primary point of contact for all regulatory agencies and respond to any inquiries or requests for information
• Collaborate with cross-functional teams to ensure that all products meet regulatory requirements and standards
• Conduct internal audits to ensure compliance with regulatory guidelines and address any non-compliance issues
• Participate in product development meetings and provide regulatory guidance throughout the process
• Review and approve labeling, advertising, and promotional materials to ensure compliance with regulations
• Monitor changes in regulations and communicate any potential impact to the company
• Participate in post-market surveillance activities, including adverse event reporting and product recalls
• Train and educate employees on regulatory requirements and updates
• Maintain accurate and up-to-date records of all regulatory activities and submissions
• Represent the company in front of regulatory agencies during inspections or audits

Qualifications:

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 5 years of experience in regulatory affairs, preferably in the Pharmaceuticals sector
• Strong understanding of FDA regulations and guidelines
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple projects simultaneously
• Attention to detail and strong analytical skills
• Proficient in Microsoft Office and experience with regulatory submission software
• Knowledge of international regulatory requirements is a plus
• Certified Regulatory Affairs Professional (RAC) certification is preferred

We Offer:

• Competitive salary and benefits package
• Opportunities for career growth and development
• A collaborative and supportive work environment
• Exposure to a wide range of regulatory projects and products

Join our team and help us ensure that our products meet all regulatory requirements and standards.