Regulatory Affairs Manager

Unicon Pharma Inc; United States; On-site; USD 80,000 - 110,000; Full time

Job summary

Unicon Pharma Inc is seeking a Regulatory Affairs professional to provide regulatory guidance to cross‑functional teams and support global regulatory submissions. Responsibilities include preparing and submitting regulatory documents, developing regulatory strategies, and ensuring compliance.

The ideal candidate will have a Bachelor's degree and 3+ years of experience in Regulatory Affairs within the pharmaceutical industry.

Preferred qualifications include knowledge of EU EMA regulations and experience with IND and NDA submissions.

Qualifications

• 3+ years of Regulatory Affairs experience in the pharmaceutical industry.
• Strong knowledge of US FDA regulations and successful submission experience.

Responsibilities

• Provide regulatory guidance to cross‑functional teams and support global regulatory submissions.
• Prepare, coordinate, and submit regulatory documents to global health authorities.
• Develop regulatory strategies, assess risks, and support business decisions.

Skills

Regulatory Affairs

Communication skills

Collaboration

Organizational skills

Education

Bachelor's degree in a relevant field

Job description

• Provide regulatory guidance to cross‑functional teams and support global regulatory submissions (Clinical, Preclinical, and CMC).
• Prepare, coordinate, and submit regulatory documents to global health authorities.
• Develop regulatory strategies, assess risks, and support business decisions through regulatory intelligence.
• Collaborate across departments and serve as a regulatory SME on study and submission teams.
• Ensure regulatory compliance and maintain health authority approvals for investigational products.

Requirements

• Bachelor's degree in a relevant field.
• 3+ years of Regulatory Affairs experience in the pharmaceutical industry.
• Strong knowledge of US FDA regulations and successful submission experience.
• Excellent communication, collaboration, and organizational skills.

Preferred

• Knowledge of EU EMA regulations.
• Experience with IND and NDA submissions.