Regulatory Affairs Manager

Job Title: Senior Specialist, Regulatory Affairs

Location: East Windsor, NJ (Onsite)

Qualifications

• Bachelor’s Degree in life sciences required with 7 years of relevant regulatory compliance experience in pharmaceutical drug development required; or Master’s Degree in life sciences required with 5 years of relevant regulatory compliance experience in pharmaceutical drug development required
• Knowledge and experience with organizing responses to Regulatory Authority requests required
• Knowledge of FDA, ICH and other guidance documents and requirements
• Knowledge of organizing responses to Regulatory Authority requests
• Strong knowledge of Health Authority regulatory requirements/guidelines
• Strong project management and computer skills (including Microsoft office)
• Strong document management experience (hard and e-copy)
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
• Strong organizational skills, written/oral communication skills and attention to detail
• Ability to manage conflicting priorities and respond in a timely, effective manner

Responsibilities

• The Senior Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements
• Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization
• Approve, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirements
• Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products
• Assist with developing and evaluating regulatory strategy
• Keep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on ForDoz products
• Author and review departmental SOPs, as well as other SOPs that may impact Regulatory Affairs
• Performs other special projects and duties as requested

Key Attributes

• Detail-oriented with strong problem-solving skills
• Proactive, self-motivated, and results-driven
• Comfortable navigating ambiguity and changing priorities
• Strong sense of ownership and accountability

**Please note this position is not eligible for employment visa sponsorship now or in future

ForDoz Pharma Corp. is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). ForDoz Pharma Corp. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics

Job Type: Full-time

Pay: $135,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• Have you prepared, reviewed, or supported regulatory submissions (e.g., IND, NDA, ANDA, BLA)?
• Have you responded directly to FDA or other Health Authority information requests?

Education:

• Bachelor's (Required)

Experience:

• regulatory : 5 years (Required)

Ability to Commute:

• East Windsor, NJ 08520 (Required)

Work Location: In person

Salary : $135,000 - $150,000