PURPOSE AND SCOPE:

Ensures overall regulatory compliance for FMCNA pharmaceutical product. Provides regulatory input to facilities in the preparation and timely submission of required information to applicable agencies. Oversees Regulatory Pharmaceuticals staff to develop expertise in the interpretation and application of appropriate regulations.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Your Responsibilities:
•    Lead global regulatory strategy and submissions across U.S., EU, Canada, LATAM, and APAC
•    Plan, author, and review eCTD submissions (IND, NDA, ANDA, MAA, variations, renewals, supplements)
•    Represent Regulatory Affairs on cross-functional teams, providing guidance on regional requirements and development pathways
•    Provide strategic input on CMC, clinical, and nonclinical documentation for global compliance
•    Coordinate electronic submissions with Regulatory Operations using Veeva Vault RIM, RIMSmart, and global gateways (FDA ESG, CESP, BfArM, Health Canada, ANVISA)
•    Monitor global regulations and communicate key changes to stakeholders
•    Prepare regulatory correspondence, briefing packages, and materials for health authority meetings
•    Manage post-approval commitments, renewals, and lifecycle activities
•    Review labeling, advertising, and promotional materials for regulatory compliance
•    Maintain relationships with health authorities and industry peers
•    Partner with Quality, Clinical, Nonclinical, and Manufacturing to align regulatory documentation
•    Improve regulatory processes and support audits, inspections, and other regulatory projects

Your Profile:
•    Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biology, or related field required; advanced degree (M.S., Ph.D., Pharm.D.) preferred
•    RAC certification or equivalent highly desirable; ongoing professional development in global regulatory strategy is a plus
•    8–10 years of global regulatory affairs experience in drug development and lifecycle management across U.S., EU, Canada, LATAM, and APAC
•    Strong hands-on experience with global eCTD submissions (IND, NDA, ANDA, MAA, variations, renewals, supplements)
•    Proven success in global registration strategy and interactions with FDA, EMA, Health Canada, ANVISA, NMPA, and other authorities
•    Deep knowledge of ICH guidelines, regional regulations, and global submission standards
•    Proficiency with regulatory information/publishing systems (e.g., Veeva Vault RIM, RIMSmart) and electronic gateways
•    Broad understanding of CMC, clinical, and nonclinical regulatory requirements
•    Strong project management, communication, and collaboration skills, with the ability to work independently in a global matrix, handle multiple complex projects, and adapt to evolving regulatory requirements
 

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION:

Bachelor’s Degree required

EXPERIENCE AND REQUIRED SKILLS:

• 8 – 10 years’ experience .
• Breadth of desired pharmaceutical experience includes: contact with manufacturing, quality, clinical and preclinical departments.
• Demonstrated success working effectively in a highly charged, stressful, and changing environment.
• Knowledge, comprehension and application of scientific principles are required. Must be knowledgeable of and have experience in applying FDA drug regulations; possess strong oral and written communication skills; and be computer proficient.
• Experience in regulatory publishing templates highly desirable.
• Strong oral and written communication skills.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.