Remote - Sr. Regulatory Affairs Associate - Pharmaceuticals

This position can be fully remote

Global Regulatory experience needed.

Demonstrated project management experience needed.

PURPOSE AND SCOPE:

Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for assigned projects. Prepares for agency interactions by writing and organizing associated documentation, including letters and briefing packages. Reviews and advises on manufacturing and control changes for marketed products, labels and clinical materials for products in development.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Provides regulatory assessment and support.
• Evaluates and assesses regulatory impact of proposed product changes.
• Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development teams.
• Provides project team representation and direction in managing information from/to other departments regarding regulatory submissions.
• Support product development teams by interpreting and strategically applying regulations, guidances and available research/information.
• Plans, prepares and submits varied regulatory filings and correspondence to FDA and other appropriate Health Authorities. Keeps to internal and federal timelines and ensures content, quality, accuracy and format of submissions comply with applicable laws, regulations and corporate standards.
• Critically reviews all types of documents for regulatory submission, including product labeling and promotional and advertising material.
• Conducts regulatory intelligence as required for in-licensing candidates and products in development.
• Ensures that all submission documentation, record keeping and reporting remain in compliance with regulatory filings and in accordance with current regulatory requirements.
• Maintains awareness of all current, pertinent regulations, guidelines, policies, procedures and practices. Analyzes changes and updates and advises and provides recommendations to the department and interested personnel as needed.
• Participates in departmental continuous improvement activities. Makes recommendations for process improvements for efficiency and accuracy of drug submissions and other processes.
• Enhances implementation of eCTD system by restructuring document format with new submissions.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.  
• May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
• May escalate issues to supervisor/manager for resolution, as deemed necessary.
• Mentor other staff as applicable.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assist with various projects as assigned by a direct supervisor.
• Other duties as assigned.

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.
• Packaging of submissions for transmission to FDA involves lifting multiple volumes each weighing up to 5 lbs.
• 10 – 15% domestic and international travel required.

EDUCATION:

Bachelor’s Degree required; Advanced Degree desirable

EXPERIENCE AND REQUIRED SKILLS:

• 5 – 8 years’ related experience; or a Master’s degree with 3 years’ experience; or a PhD without experience; or equivalent directly related work experience.
• Demonstrated working knowledge of scientific principles and domestic regulatory requirements is essential, as well as the ability to interpret and strategically apply such knowledge.
• In-depth knowledge of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Investigational New Drug Applications (INDs), sNDAs/ANDS, CBEs., Annual Reports and PSURs.
• A strong understanding of US drug or biologics guidelines and regulations.
• Previous experience in preparation of RA documents is required.
• Able to work independently with minimal direction.
• Able to work collaboratively in a team setting.
• Highly detail-oriented, well organized and driven to meet deadlines and program goals.
• Excellent interpersonal, verbal and written communication skills, including the ability to make effective and persuasive presentation.
• Good computer skills in Microsoft Office applications.
• Prior experience with eCTD submissions highly preferred.

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.