What are the responsibilities and job description for the Regulatory Affairs Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Duration: 12 months contract, extendable up to 36 months.
- The Client team is seeking a Regulatory Affairs Specialist to contribute to the development and execution of effective regulatory strategies for investigational products.
- The successful candidate will serve as a regulatory contact within an internal matrixed team environment.
- Execute integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients.
- Provide support to assigned clinical study and global regulatory teams.
- Assess regulatory program risks for likelihood and impact; help to establish mitigation strategies.
- Plan and prepare submissions to regulatory authorities, related to IND maintenance.
- Advice on regulatory requirements, expected outcomes, and changes to landscape.
- Strong information seeking skills and ability to work under moderate supervision.
- Bachelor's degree in a life sciences discipline.
- A minimum of 5 years of relevant regulatory experience with drug or therapeutic biologic products required.
- General knowledge of the drug development process and US regulatory requirements, including expedited development programs for drugs to treat serious conditions.
- Strong verbal and written communication skills.
- Strong organizational skills, ability manage conflicting priorities and adhere to tight timelines.
- Proven ability to work with a high level of integrity, accuracy, and attention to detail.
