This growing biopharmaceutical company is developing medicines for patients who suffer from serious genetic diseases and cancers. They have one approved product and another program currently in Phase 2 trials. They are seeking a Regulatory Affairs Consultant who can help to develop and execute global regulatory strategies for the company’s rare disease and oncology programs. This engagement will be approximately 20-30 hours a week for about 3-6 months. This is a remote role.
- Develop regulatory strategies for rare disease and oncology programs in development
- Provide guidance and support to cross-functional teams, and execute defined regulatory activities.
- Maintain regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and post-marketing submission deliverables.
- Serve as regulatory lead or co-lead on assigned drug project teams, providing regulatory guidance and recommendations that are in line with the company goals, international laws, and regulations, including but not limited to:
- Phase 2 – 3 development activities
- Health authority meetings related to drug development and marketing applications
- Lead and/or support strategy and execution of amendments/supplements and other policies and procedures as assigned
- Conduct Regulatory Intelligence related to the assigned programs and disseminate relevant information to Sr. Management and cross-functional teams.
- Assist with all regulatory business development efforts as needed
- Manage other regulatory activities as assigned, which may involve nonclinical studies and strategies, and commercial activities
- Bachelor’s degree in a scientific field is required. Advanced degree such as PharmD, MD, or PhD preferred
- A minimum of 10 years of Regulatory Affairs experience with pharmaceutical drugs and/or biologics.
- Regulatory experience with rare disease programs and/or oncology experience highly desired.
- Must have track record of filing successful INDs, CTAs, NDAs or BLAs.
- Must have strong experience working directly with FDA and other health authorities.
- Be well-versed in the drug development process and regulatory requirements, and have a good understanding of the underlying science.
- Global/Ex-US Regulatory filing experience (EMA, Asia Pacific, etc) required.
- Excellent written and verbal communication 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; management also of non-regulatory functional activities is preferred
- Thorough understanding and demonstrated experience with eCTD submission requirements, utilizing document templates, and knowledge of global operational regulations and guidelines
- Excellent written and oral communication skills
- Demonstrated influencing and leadership skills
- Fluent with Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat PDF rendering software
Note: All contractors must be authorized to work in the United States. H1B sponsorship is not available.