Mgr, Regulatory Affairs Pharma - HealthCanada

PURPOSE AND SCOPE:

Ensure overall (other than auditing responsibilities) regulatory compliance for FMCNA pharmaceutical product. Provides regulatory input to facilities in the preparation and timely submission of required information to applicable agencies. Manages Regulatory Pharmaceuticals staff to develop expertise in the interpretation and application of appropriate regulations. Responds to FDA or district office requests.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Manage the company’s pharmaceutical products and the associated RA staff. Serves as a regulatory representative on Product Development Teams and provide regulatory support and advice for the team. Responsibilities include:

• Facilitates regulatory strategy development and other compliant alternatives to product team.
• Facilitates clinical strategy development in providing regulatory guidance and intelligence on acceptable approval strategies.
• Assists in the short and long term schedule planning for the Product Team.
• Authoring, reviewing and coordinating quality submissions to regulatory agencies for viable product strategies and product submission.
• Assists in interactions with the FDA and other regulatory agencies.
• Builds professional relationships with the FDA project managers and other key personnel.
• Provides strong leadership and support within the department. Provides coaching and counseling and advice to direct report employees. Provides feedback to employees on a consistent basis. Works with employees to develop clear and concise development plans to ensure the advancement of future talent.
• Responsible for the annual assessment for all direct report employees, utilizing the company’s performance management tools.
• Ensures FDA commitments are met in a timely manner.
• Provides regulatory review, feedback and /or approval for relevant documents, including advertising and promotional materials.
• Arranges and prepares for meetings, teleconferences, and other communications with the FDA (including read-ahead packages and/or other necessary documentation). Where needed, prepare and distribute meeting minutes and follow-up notes.
• Liaises with Regulatory Operations for timely submission of electronic and paper submissions.
• Provides opportunities for on-going job-related education to the pharmaceuticals RA staff and provides regulatory input and feedback for subcontractor selection and management.
• Provide technical guidance.
• Assist with various projects as assigned.
• 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.
  
  
  

SUPERVISION:

• May be responsible for the direct supervision of various levels of Pharmaceutical Regulatory Affairs staff.
  
  
  

EDUCATION:

• Bachelor’s Degree required; Advanced Degree desirable
  
  
  

EXPERIENCE AND REQUIRED SKILLS:

• 6 – 8 years’ related experience.
• 3 years’ supervisory or project/program management experience preferred.
• Breadth of desired pharmaceutical experience includes: contact with manufacturing, quality, clinical and preclinical departments.
• Required skills include a history of 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.

This is a fully remote position. This person should be a subject matter expert on Regulatory Affairs as it relates to HealthCanada.

• Provides regulatory input to facilitate the timely preparation and submission of the required information to applicable agencies specializing in Canadian regulatory affairs.
• Manage the company's pharmaceutical products with a specialty in Canadian Regulatory Affairs.
• Facilitates regulatory strategy development and other compliant alternatives for the product team to register products globally, focusing on Canada.
• Offer guidance to departments on how to design, develop, evaluate, and market products in Canada.
• Authoring, reviewing, and coordinating quality submissions to regulatory agencies (Health Canada)
• Extensive knowledge of applicable government regulations with a focus on Canada.