Regulatory Specialist
Overview
Swiftwater Group provides advice to its clients regarding the development
of their pharmaceutical and biotech products, at all stages of development.
The Regulatory Specialist is responsible for providing regulatory guidance
and expertise in the compiling, writing, and maintaining of all documentation
related to a US regulatory filing. Individuals at Swiftwater Group work with
multiple clients at one time, and therefore must have very good multi-tasking
and interpersonal skills.
Qualifications
Education:
- The candidate should have a Bachelor’s degree in a scientific
or medical discipline
Experience:
- Candidates should have 2 or more years supervisory experience
in regulatory affairs, and at least 5 years experience in the pharmaceutical
industry
Industry Knowledge:
- Broad understanding of regulatory affairs (RAPS certification
preferred)
- Excellent working knowledge of FDA regulations and processes
- Working knowledge of international regulations a benefit, but not
required
Skills:
- Excellent communication skills (written as well as formal and
informal oral presentations)
- Experience with the preparation, organization, submission, and
maintenance of regulatory submission documents
- Professional demeanor
- Excellent organizational skills and ability to pay strict attention
to detail
- Ability to work both independently and as part of a team
- Ability to use and manipulate electronic databases is highly desirable.
- Knowledge of global regulatory requirements desirable.
Responsibilities
- Develop and execute regulatory strategies
- Provide advice and hands-on management of regulatory document preparation,
submission, and maintenance
- Serve as point of contact for client’s regulatory communications
- Prepare client for regulatory meetings
- Represent client in interactions with regulatory authorities
