Fresenius Medical Center Regulatory Affairs Associate I, Operations with eCTD / Publishing / Formatting in Waltham, Massachusetts

Fresenius Medical Care North America (FMCNA) is the premier health care company focused on providing high quality care to people with renal and other chronic conditions. FMCNA designs, manufactures and distributes a comprehensive line of renal pharmaceuticals, dialysis equipment and disposable products.

Rewarding. Innovative. Challenging. That’s what defines a Regulatory Affairs career at Fresenius. From inception to final approval, we’ll rely on you to successfully guide our dialysis products through their entire life cycle providing invaluable expertise every step of the way. Through it all, you’ll take pride in knowing you’re making a profound difference in the lives of patients affected by kidney disease.

The Regulatory Affairs organization at FMCNA is responsible for all FDA submissions related to both our Pharmaceuticals and Medical Devices products. The Pharma organization where this role sits is responsible for Renal Pharmaceutical products at https://fmcna.com/renal-pharmaceuticals/ designed to meet our dialysis patient’s needs. Your familiarity with Pharmaceutical products and associated FDA submissions, your insights into Chemistry, Manufacturing, and Controls (CMC), Promotion and Advertising, Labeling and Change Control, your exemplary writing skills, your attention to detail and your ability to be both a humble and knowledgeable team member are some of the keys to your success at FMCNA. Our refined submission processes, our knowledgeable, industry-savvy team and extremely strong relationship with FDA, are just a few of the great reasons for making FMCNA the next destination for your career!

Our Regulatory team participates in all FMCNA new product development teams. In some companies, Regulatory Affairs is just another support organization; submissions “pass through” those groups with little more expected beyond monitoring the submission process. FMCNA is different. As a result, we offer a great opportunity to really broaden your skills. At FMCNA, the Regulatory Affairs group truly owns the FDA relationship and is totally responsible for “leading, guiding, project managing” submissions, as well as “interacting” with all parts of the FMCNA product development team.

What will you do at Fresenius?

  • You will prepare FDA submissions for product changes to ensure timely approvals working primarily on Amendments (IND) and Supplements (ANDA/NDA, Annual Reports, Safety Reports, Change Controls).

  • The teams work with cross-functional team members from Engineering, R&D, Clinical/Medical, Biocompatibility, Marketing, Quality, Human Factors and other technical experts to resolve potential regulatory issues and questions from regulatory agencies.

  • You will provide support for currently-marketed products, including reviewing product/manufacturing process changes (change controls), supplier changes, n reports, and product labeling.Our more senior roles come with the expectation of additional responsibilities such as:

  • You will work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.

  • You will be expected to exercise solid judgment in selecting methods, techniques and evaluation criteria for obtaining results.

  • You will add to your knowledge base by networking with key contacts outside your own area of expertise.

There is no such thing as the perfect candidate, but ideally we look for as many of the following Technical and Professional Competencies as possible!

Technical Competencies:

  • Knowledge of the pharma Regulatory Affairs discipline throughout the product lifecycle, including Chemistry, Manufacturing, and Controls (CMC), Promotion and Advertising, Labeling, Change Control, etc.

  • Knowledge of US laws, regulations, and guidance’s that affect assigned devices

  • Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate to product development and labeling regulatory activities for assigned devices

Our more senior roles come with the expectation of additional responsibilities such as:

  • Ability to influence and partner with cross-functional teams

  • Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval

  • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data

  • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks

Professional Competencies:

Our more senior Regulatory roles come with the expectation of additional responsibilities such as those listed below. We would not normally expect these competencies of an entry level Regulatory person, but would certainly value any that are present.

  • Demonstrated ability in analytical reasoning and critical thinking skills

  • Strong capability to contribute and lead in a team environment

  • Strong business acumen and ability to see the business drivers outside of Regulatory Affairs

  • Excellent communication skills; both oral and written

  • Strong interpersonal skills with the ability to influence others in a positive and effective manner through technical excellence and mutual respect

  • Demonstrated ability to contribute to a continuous learning and process improvement environment

  • Capacity to react quickly and decisively in unexpected, fluid situations

  • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies

  • Focused ability to influence operational excellence and performance metrics

  • A risk averse nature when needed, with the ability to identify potential solutions to complex problems

PURPOSE AND SCOPE:

Responsible for assisting in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals and device products in the domestic and international markets as assigned. Responsible for the maintenance systems designed to ensure compliance with electronic submission requirements and document management systems.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Developing professional expertise; applies company policies and procedures to assist in the day-to-day procedures used to support regulatory submission (drugs and device) and publishing activities.

  • Assists in the maintenance of an archiving/document management system.

  • Responsible for producing and tracking FMCNA regulatory submissions and submissions-compliant documents in the electronic format (eCTD and eFiling).

  • Responsible for assisting in implementing and maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, and electronic submissions.

  • Works with department and external groups as assigned.

  • Participates in the evaluation and provide input for new department technologies and collaborate with intra-departmental resources to ensure adherence to infrastructure standards.

  • Compiles, publishes, QC, and validates documents for FDA submission.

  • Troubleshoots document issues in MS Word and Adobe Acrobat.

  • Provides editing and formatting support.

  • Supports the transition from legacy to electronic submissions.

  • Coordinates with regulatory staff to compile regulatory submissions.

  • Ensures that all required documents are received and formatted appropriately and in a timely manner.

  • Demonstrates knowledge of electronic submission requirements and prepares for future initiatives and requirements.

  • Participates in a document management system to align document access and storage with RA electronic submission needs.

  • Assists in development of overall project timing.

  • Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors.

  • Exercises judgment within defined procedures and practices to determine appropriate action.

  • Builds productive working relationships.

  • Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.

  • Assists with various projects as assigned by direct supervisor.

  • Other duties as assigned.

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. In lieu of degree, additional years of relevant experience may be considered.

  • Candidates with Library Science Degrees with applicable background and experience will be considered.

EXPERIENCE AND REQUIRED SKILLS:

  • 2 – 5 years of experience in a Regulatory Affairs environment; 2+ years in pharmaceutical industry.

  • Experience with Document Management a plus.

  • Understanding of document management processes in a regulated pharmaceutical/device environment.

  • Demonstrated ability to work to manage projects as part of a team.

  • Must be highly proficient in MS Office (emphasis on MS Word), Adobe Acrobat (version 5.0 or higher).

  • Hands on experience with document management systems.

  • Knowledge of EDM, RIM and electronic publishing software preferred. Experience with electronic submissions, specifically eCTD, or eCopy a plus.

  • Outstanding interpersonal and communication (written and verbal) skills.

  • Detail oriented, proactive, effective task planning and coordination of activities.

  • Strong software troubleshooting skills highly desirable.

  • Experience with Adobe, desktop publishing software, document management solutions, database software and Microsoft Office.

  • Detail oriented; ability to work under deadlines; strong organizational skills required.

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