Bloomington, IN Req ID:
Sr. Regulatory Affairs AssociateBusiness:
IndianaLocation of Position:
Bloomington, IN Shift:
1st Job Description:
The Senior Regulatory Affairs Associate is responsible for maintaining knowledge of current regulatory agency guidance documents and regulations and evaluating and communicating the facility impact of these global regulatory guidance documents. The Senior Regulatory Affairs Associate will have the following responsibilities: maintenance of Baxter Drug Master Files, perform regulatory assessment for Supplier Notices of Change (SNCs), support the Manufacturing, QC Microbiology and IT Validation departments via document review and approval, and author Client Change Notifications (CNSs). This position is also responsible for upgrading the Drug Master Files to comply with BaxEdge requirements and convert into the eCTD format.
- Compile and submit, in a timely manner, regulatory documents according to regulatory requirements.
- Respond to regulatory authorities questions with strict deadlines.
- Maintain regulatory files in a format consistent with requirements
- Develop regulatory strategy project plans.
- Coordinate, author and submit amendments for Baxter Drug Master Files.
- Participate on the Drug Master File Task Force, and support initiative to convert Baxter Drug Master Files into eCTD format and comply with BaxEdge requirements.
- Collaborate with global regulatory counterparts and PharmaPartners to develop global regulatory strategy, as applicable.
- Evaluate and interpret draft and final regulations as well as global guidance documents (e.g. EU and Canada, Asia-Pac, Brazil, etc.).
- Disseminate draft and final regulations and guidance documents to pertinent departments for gap assessment.
- Assess supplier changes for regulatory impact to global regulatory applications and identify regulatory hold issues as necessary.
- Provide guidance to projects teams in the area of design and analysis for straightforward projects.
- Lead internal regulatory project improvement teams or continuous improvement efforts.
- Revise regulatory Standard Operating Procedures.
- Responsible for the Client Change Notification System.
- Support client change notification process, by writing change notifications and providing a regulatory impact evaluation.
Doing Work that Matters:
- Scientific knowledge
- Written and Verbal communication skills
- Knowledge of regulations
- Negotiation skills
- Technical system skills (e.g. word processing, spreadsheets, databases, online research)
- Manage multiple projects and deadlines
- Ability to identify compliance risks and escalate when necessary
- Bachelor's degree or country equivalent in pharmacy or related scientific discipline with a minimum of 3 - 4 years regulatory or equivalent experience such as Quality or Technical Services within a pharmaceutical company, CRO, or similar organization.
- Higher degree/PhD will be an advantage.
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
Baxter International Inc. (NYSE:BAX), through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. Baxter had 2012 sales of $14.2 billion and has approximately 50,800 employees.