Regulatory Associate

We are a biological research and development company.

Competitive compensation and benefits package
Hybrid remote/onsite work schedule
Professional development, mentorship, and training programs
Medical/Dental/Vision
401k with match
Paid time off
Life insurance and AD&D coverage

Job Details:
Our company is seeking a dynamic and experienced Regulatory Associate to join our team. This position is integral to the success of our operations and offers a unique opportunity to make a significant impact on our business. The successful candidate will be responsible for ensuring that our company meets all regulatory standards and procedures in the industry. This role requires a strong understanding and application of scientific and regulatory knowledge in managing submissions and maintaining compliance.

Responsibilities:

• Lead and manage all regulatory submissions to ensure timely approvals.
• Develop and implement regulatory strategies and action plans.
• Maintain up-to-date knowledge of regulatory affairs and changes in the medical industry.
• Interpret regulatory rules and guidelines and ensure that they are communicated through corporate policies and procedures.
• Coordinate with various departments to ensure that all regulatory processes are followed.
• Review and approve all promotional materials to ensure regulatory compliance.
• Participate in internal and external audits.
• Provide regulatory input and advice throughout the product lifecycle.
• Prepare and manage regulatory documentation and reports.
• Liaise with regulatory authorities and represent the company at meetings and inspections.

Qualifications:

• A Bachelor's degree in Biological Sciences, Pharmacy, or a closely related field is required. A Master's degree is preferred.
• Minimum of 3 years of experience in regulatory affairs in the medical industry.
• Demonstrated experience with managing regulatory submissions and maintaining compliance.
• Strong knowledge of relevant industry regulations and standards.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple tasks simultaneously.
• Proficient in Microsoft Office Suite and regulatory databases.
• Ability to work independently and as part of a team.
• Strong analytical and problem-solving skills.
• Ability to interpret and apply knowledge of laws, regulations, and policies related to regulatory affairs.
• Self-motivated with a strong attention to detail.

Join our team and contribute to our mission of improving health and wellness through innovation, quality, and commitment. We offer a competitive salary and benefits package, along with the opportunity for personal and professional growth. If you have the required skills and experience, we would love to hear from you.