Regulatory and Government Affairs
Senior Specialist, RA Operations
Address: Bengaluru, Bengaluru, Karnātaka, 560066, India
Job ID: R0254598
Location Type: Hybrid
- Overview
- Job Description
- Success Profile
- Rewards
- Connect
As a Clinic Manager at Fresenius Medical Care, you’ll manage the daily operations of our outpatient centers. More importantly, you’ll be the key driver in carrying out our mission: To deliver superior care that improves the quality of life of every patient, every day, setting the standard by which others in the health care industry are judged. This is accomplished by hiring, developing and inspiring a multi-disciplinary team, collaborating with physicians, tracking and delivering superior patient outcomes and monitoring regulatory and safety requirements. Strong management skills are required and prior direct patient care experience is needed for occasions when the team needs a helping hand.
Patient Care Technicians (PCTs) at Fresenius Medical Care support and collaborate with RNs to provide dialysis treatment to several patients at a time while maintaining the functionality of the clinic. This involves prepping and testing equipment, reviewing treatment sheets, and opening the clinic at 4am for first shift. PCTs have a combination of technical skills and genuine passion needed to develop deep relationships with patients and improve their quality of life. Qualified candidates have prior customer service, healthcare and direct patient care experience, and will have the opportunity to learn the discipline of dialysis.
Fresenius Medical Care nurses are on the front line of patient care, improving the quality of life of every patient, every day. That means providing dialysis care to 10-12 patients at any given time, and collaborating with our multi-disciplinary team to deliver a unique care plan to each one of them. This role is all about relationships and the bond you’ll create with patients and their families. Prior dialysis nursing experience is helpful, but many successful candidates come from a background in ICU, PCU and/or surgery.
Inpatient RNs at Fresenius Medical Care perform dialysis treatments on an acute patient population in a hospital setting, including ICU, ER, Rehab, and Med/Surg units. What makes this role truly unique is the level of autonomy you’ll enjoy. Inpatient nurses are specifically accountable for administering and assessing each patient’s treatment plan. And because dialysis is a critical treatment for many hospital procedures and health conditions, you’ll have the opportunity to work with a wide variety of patients. Ideal candidates possess leadership skills and independence needed to make quick decisions in a fast-paced environment. Must be capable of educating patients and providing exceptional customer service to our partners. Six months to one year of dialysis experience or some form of critical care nursing experience are also required.
Job Description
JOB TITLE:
Senior Regulatory Affairs Associate, Global eCTD Operations
EXEMPTION STATUS:
Exempt
POSITION LEVEL:
JOB CODE:
JOB GRADE:
JOB FAMILY:
SA-Regulatory Affairs
VERSION:
PURPOSE AND SCOPE:
The Senior Regulatory Affairs (RA) Associate, Operations, plays a critical role in the planning, preparation, and management of global electronic Common Technical Document (eCTD) submissions that support the approval and maintenance of licensed pharmaceutical products worldwide.
This position ensures full compliance with global electronic submission requirements, including those of the U.S. FDA, EMA, China NMPA, Health Canada, LATAM, and other regulatory authorities and contributes to continuous improvement of global submission standards, systems, and processes within the Regulatory Affairs Operations function..
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Serve as a subject matter expert (SME) in global eCTD publishing and submission management, ensuring compliance with regional regulations and technical requirements (U.S., EU, China, APAC, LATAM).
- Lead the preparation, compilation, quality check, validation, and delivery of high-quality global regulatory submissions using eCTD and related formats.
- Collaborate cross-functionally with Global and Local Regulatory Affairs teams to ensure timely, accurate handoff and harmonization of submission components across regions.
- Apply deep understanding of global eCTD structure, lifecycle management, and validation standards to troubleshoot and resolve technical issues.
- Interpret and implement evolving global eCTD and electronic submission guidance, proactively ensuring readiness for new regulatory initiatives and format updates.
- Develop, maintain, and enhance departmental templates, standards, and workflows for electronic submissions and regulatory information systems.
- Manage submission content in accordance with company policies, ensuring data integrity, version control, and compliance across all submission types (IND/CTA, NDA/MAA, DMF, lifecycle updates, PSURs, etc.).
- Partner with internal IT and publishing teams to optimize global systems, technologies, and submission infrastructure (e.g., Veeva, RIMSmart).
- Provide mentorship and training to junior publishing or RA Operations staff, fostering consistency and global best practices in eCTD publishing.
- Uphold the company’s Code of Business Conduct and all applicable regulatory, state, and federal compliance standards.
- Participate in cross-functional initiatives and special projects to advance global regulatory operations efficiency and compliance.
Additional responsibilities may include a 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 represent those employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
EDUCATION:
Bachelor’s degree in a scientific, technical, or related discipline required (e.g., Life Sciences, Pharmacy, Chemistry).
Advanced degree preferred.
An equivalent combination of education and relevant regulatory experience may be considered.
EXPERIENCE AND REQUIRED SKILLS:
- 5–8 years of hands-on experience with global eCTD publishing, submission lifecycle management, and regulatory operations.
- Proven experience preparing, compiling, and submitting complex global eCTD sequences for multiple markets (U.S., EU, China, LATAM, APAC).
- Demonstrated mastery of eCTD structure, lifecycle sequences, validation criteria, and submission portal requirements, including Gateway, CESP, and BfArM.
- Proficiency with regulatory information and document management systems, particularly Veeva Vault RIM and RIMSmart; experience with eCTD validation and publishing tools required.
- Strong technical skills in MS Word, Adobe Acrobat, and other authoring/publishing software with advanced troubleshooting capabilities.
- Deep understanding of the global drug development process and the regulatory frameworks governing electronic submissions.
- Exceptional attention to detail, organizational discipline, and ability to manage multiple global submissions under tight deadlines.
- Excellent written and verbal communication skills with the ability to convey complex technical and regulatory information clearly.
- Collaborative team player who thrives in a fast-paced, cross-functional global environment and demonstrates strong problem-solving and project management skills.
Success Profile
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
Leadership
Communicator
Compassionate
Problem-solver
Motivational
Good Listener
Success Profile
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
Commpassionate Patient Care
Empathetic
Team Player
Detail Oriented
Efficient
Responsible
Success Profile
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
Communicator
Compassionate
Detail Oriented
Relationship Expertise
Facilitator
Leadership
Success Profile
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
Compassionate
Flexible
Independent
Quick-thinking
Patient
Responsible
“I successfully completed the RN program and went on to hold the position of Staff RN, Charge Nurse, and finally Clinical Manager.”
Rosalyn,
Clinical Manager
Clinical Manager
“Every day I walk in I am changing lives for the better and working to inspire my patients.”
Andrew,
Patient Care Technician
Patient Care Technician
“I am a member of an outstanding team that helps patients gain more control, achieve tangible goals, and live better lives.”
Tony,
Outpatient Services RN
Outpatient Services RN
“My goal is to make sure that our patients keep their mobility and quality of life. This goal is really personal for me. My own father always had really bad vasculature in his leg and never had access to the kind of care we offer — eventually he lost blood flow and mobility. Knowing what he went through makes me even more committed to our mission.”
Warren J.
Azura Regional Vice President
Azura Regional Vice President
We've got your back.
We fully believe that dedication and passion should be recognized and rewarded. That’s why we offer a competitive compensation and benefits package to all of our employees. Our benefits provide the flexibility, choice and support you need to be at your best as you play a vital part in helping patients live longer, better and healthier lives.
Healthcare
Continuing Education
Paid Time Off
Collaborative Environment
Additional Perks
401(k) Retirement Saving
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