Sr. Manager, Global Regulatory Affairs
Sr. Manager, Global Regulatory Affairs
Baxter International
Remote
Summary:
Responsible for the implementation of complex global regulatory strategies, obtaining and maintaining marketing authorizations for biologic products, and communication of general regulatory requirements in support of Pharma Partner products. Primary focus includes support of the Module 3/CMC submission sections.
Responsibilities:
- Act as the Global Regulatory Lead for hemostat/sealant product(s) registered as biologic/combination;
- Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards;
- Assess impact of new regulations and provide feedback;
- Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks;
- Provide technical and strategic input for regulatory decisions aligned with business strategy;
- Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups;
- May act as primary contact for meetings with regulatory authorities including planning and leadership;
- Maintain appropriate communication within the RA function, with GBU Marketing, and with other functions primarily at the project team level;
- Plan and manage complex projects and prioritize workload;
- Initiate, manage and maintain operational activities in support of new and existing marketing authorizations;
- May manage regulatory budget at project level;
- May represent Baxter interests in industry and working groups;
- Set team, group, or service objectives to assure they align with the regulatory strategy;
- May provide direct supervision of individuals including mentoring, performance management and staffing decisions.
Qualifications
- Bachelor’s degree or country equivalent in a scientific discipline;
- Minimum of 5 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization;
- Applications knowledge of biologics preferred;
- Experience with FDA regulations;
- Scientific knowledge;
- Ability to manage complex projects and timelines in a matrix team environment;
- Strong interpersonal and communication skills;
- Strong negotiation skills;
- Technical system skills (e.g. word processing, spreadsheets, databases, online research);
- Ability to work effectively in multinational/multicultural environment;
- Ability to identify compliance risks and escalate when necessary.
Don't forget to mention EuroPharmaJobs when applying.
