This biotechnology company is focused on novel biological and drug delivery technologies. The Regulatory Affairs CMC contractor will provide support in the development and implementation of global regulatory CMC strategies for marketed and development products. This individual will lead or support regulatory activities for internal and external programs and will work closely with cross-functional subject matter experts to ensure effective execution of regulatory strategy, regulatory requirements, and the timely submission and approval of global regulatory filings for external collaboration Partners. Working with the entire RA group, the contractor will also contribute to the development, implementation and maintenance of a comprehensive knowledge management capability in the RA group to support the company’s and Partners’ regulatory needs. This engagement will be approximately 40 hours a week and it is a REMOTE role.
RESPONSIBILITIES:
- Coordinate and review regulatory CMC submission documents and development activities to support regulatory filings
- Effectively work with internal, external and vendor resources to manage global regulatory activities
- Interpret regulations and provide well-reasoned regulatory guidance to cross functional project team
- Support or lead the preparation of health authority meeting materials and lead responses to requests for information
- Support RA management with development and implementation of working procedures, standard operating procedures and policies
- Research, prepare, and present on global regulatory topics to internal and external stakeholders
- Assure compliance with all applicable (domestic and international) regulations including regulatory change management
- Monitor industry and regulatory trends and be able to apply learnings and provide guidance related to such trends to regulatory and functional teams
- Compile and maintain regulatory files and trackers for regulatory information and submission preparation
EXPERIENCE AND QUALIFICATIONS:
- Minimum of a Bachelors’ degree in science with at least 3 years’ experience in Regulatory Affairs CMC in the biotechnology or pharmaceutical industries
- Experience writing CMC sections for INDs, CTAs, NDAs, BLAs, MAAs, etc.
- Demonstrated experience with Health Authorities submissions and a working knowledge of FDA/EMA regulations, the regulators, and the approval process
- Must have experience in biologics.
- Experience in regulatory management of commercial products is a plus
- Proven experience and success in applying regulatory knowledge to various situations
- Excellent operational skills including planning, organizing and the ability to deal effectively with a variety of personnel in other functional groups both internally and outside the company
- Excellent writing, communication, and interpretive skills
- High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently
- Experience filing and knowledge of European/global submissions is a plus
NOTE: All applicants must be authorized to work in the US. H1B transfers cannot be accommodated.