Vice President, Regulatory Affairs - Virginia Beach, United States - Civica Rx

Civica Rx Virginia Beach, United States

1 week ago

Description

About Civica:
Civica is a social welfare organization formed in 2018 by health systems and philanthropies to tackle chronic generic drug shortages and high prices in the United States. Led by a skilled team of healthcare and pharmaceutical industry professionals, Civica has partnered with over 55 health systems, comprising more than 1,500 hospitals, demonstrating its commitment to making quality medications accessible to all.

Civica's initiative, CivicaScript, aims to extend its impact by entering the outpatient pharmacy sector and producing insulins at lower prices than current market offerings. This endeavor, set for 2024, will greatly benefit individuals with diabetes, ensuring they can afford vital medications without financial strain.

Job Description:
Civica, Inc. is seeking a Vice President, Regulatory Affairs to bolster its mission of providing affordable medications to patients in the United States. The ideal candidate will lead regulatory efforts to secure the supply of generic injectable medications and insulin biosimilar analogs, aligning with Civica's goal of prioritizing patient well-being.

Responsibilities:

Direct Regulatory Affairs for sterile injectable, non-sterile, and biologic/biosimilar product development
Manage regulatory milestones for generic and biosimilar products, assessing success probabilities and implementing risk mitigation strategies
Oversee documentation compilation for FDA submissions and regulatory authority correspondence
Lead global CMC regulatory strategies for development projects and marketed products
Ensure regulatory compliance and consistency for assigned products
Build relationships with internal and external stakeholders to drive regulatory innovation

This role offers flexible remote work with occasional travel to Civica's facilities in Virginia and Utah.

Qualifications:

Minimum 20 years of experience in global CMC regulatory affairs
Demonstrated leadership in NDA/ANDA/BLA/IND/IMPD/CTA submission and approvals
Expertise in biologics/biosimilar and sterile injectable fields preferred
Proven success in developing innovative CMC regulatory strategies
Excellent strategic, collaboration, and communication skills

Additional Information:

Ability to travel domestically and internationally as needed, up to 20%

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