Our client is one of the largest providers of reproductive healthcare drugs. They have one approved product and a robust pipeline of women’s health programs in development. They are seeking a Senior Regulatory Affairs Consultant who can provide strategic regulatory expertise and leadership for the company until a new Head of Regulatory & Quality can be hired. Reporting into the CEO, this engagement will be approximately 40 hours a week for about 3-6 months. This is a remote role.
- Lead regulatory affairs and for approved and pipeline products (including business development assessments).
- Develop and execute regulatory strategies and provide regulatory support for all operational, manufacturing, clinical and nonclinical activities.
- Lead interface with the FDA and other regulatory agencies as needed.
- Lead, manage and prepare regulatory submissions for on-market and development programs (i.e., ANDA/NDA, Pre-IND/IND, REMS) including supplements, annual reports, IND safety reports, study protocols and study reports) to ensure compliance with FDA and other requirements.
- Provide regulatory advice for all development activities, including review or authoring of essential regulatory documents.
- Provide oversight of quality assurance.
- Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation. Ensure consistency, completeness, and adherence to standards for all regulatory submissions.
- Provide regulatory support for CMC, REMS and other activities including regulatory manufacturing submission documents, quality and safety oversight.
- Develop, implement and maintain regulatory process, procedures and compliance operations.
- Keep senior management informed and advised of all key regulatory and quality assurance issues.
- Bachelor’s degree in a scientific field is required. Advanced degree such as PharmD, MD, or PhD preferred
- A minimum of 15 years of Regulatory Affairs experience with pharmaceutical drugs and/or biologics.
- Regulatory experience with Women’s Health programs desired, but not required.
- Demonstrated track record of expertise and hands-on execution of regulatory affairs in small-medium pharmaceutical company.
- Broad experience across NDA, ANDA, 505b2, IND, CMC, clinical, REMS, and other domains, and ability to effectively anticipate, prevent and solve challenges.
- Excellent written and verbal communication skills.
- Demonstrated influencing and leadership skills.
- Excellent project management skills, with the ability to manage multiple projects and prioritize appropriately.
- Ability to prioritize multiple urgent priorities and experience with wearing multiple hats.
- Strong interpersonal and agency management skills.
Note: All contractors must be authorized to work in the United States. H1B sponsorship is not available.