Remote ANDA Regulatory Strategist

Pharmatech Associates; San Francisco (CA); Remote; USD 120,000 - 160,000; Full time

Job summary

A prominent pharmaceutical consultancy is looking for a highly experienced Regulatory Consultant to guide and support their regulatory strategy and submissions. This remote role requires a proven track record in ANDA submissions and a strong understanding of FDA regulations. The successful candidate will work closely with executive leadership and manage the successful registration and commercialization of products. A minimum of 10 years of industry experience is needed, along with an advanced degree in a relevant field.

Qualifications

• Minimum of 10 years of experience in filing global regulatory applications.
• Proven track record of successful ANDA approvals.
• Strong knowledge of FDA guidance documents.

Responsibilities

• Lead the development of regulatory strategies and objectives.
• Manage ANDA preparation and submission processes.
• Act as the primary company contact with the US FDA.

Skills

Regulatory strategy

ANDA preparation

FDA regulations

Regulatory guidance

Strong knowledge of 21 CFR Parts 210, 211, 314

Education

Advanced degree in science or biomedical engineering

Job description

A prominent pharmaceutical consultancy is looking for a highly experienced Regulatory Consultant to guide and support their regulatory strategy and submissions. This remote role requires a proven track record in ANDA submissions and a strong understanding of FDA regulations. The successful candidate will work closely with executive leadership and manage the successful registration and commercialization of products. A minimum of 10 years of industry experience is needed, along with an advanced degree in a relevant field.