Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
The Regulatory Affairs Specialist develops and executes the regulatory submissions plans, ensuring deadlines are met and documents are properly formatted, complete, and in compliance with pharmaceutical/biologics regulatory requirements. The Sr. Specialist will plan and execute the regulatory aspects of projects ensuring that regulatory submissions are complete, properly formatted, and compliant with regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Prepares international pharmaceutical regulatory submissions as necessary to meet the Company’s product launch timelines, including: drafting, reviewing, and editing of submissions in eCTD format; collection of documentation, formatting and compilation of submission documents.
Work closely with project teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.
Reviews and approves change controls for specification, manufacturing process, labeling and other changes to insure compliance with FDA and international government requirements, including compliance with cGMP, GDP, GDocP, and GCP requirements.
Communicates regulatory requirements for clinical, CMC, and preclinical regulatory submissions for investigational and marketed products to project teams.
Drafts and maintains applicable policies and procedures to support and define the regulatory affairs function.
Performs searches for pertinent changes in regulations, and provides notice and summary of the impacts of the change to the business.
Compiles and maintains regulatory records for regulatory activities and applications.
Performs other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Travel 0-10% Domestic, International
EDUCATION and/or EXPERIENCE:
Bachelor’s degree required, focus in the area of chemistry, biology or related science desired
Regulatory Affairs Certification (RAC) desired
5-7 years’ experience in the pharmaceutical industry
5-7 year’s pharmaceutical or biologic EMA or MHRA submissions experience
Global regulatory submissions experience desired
Experience with cGMP, GDP, GDocP
Excellent English written and verbal communication skills
Ability to read, analyze, and interpret common scientific and technical journals, reports and legal documents
Must have analytical skills (root cause analysis, risk management, problem solving and prevention of re-occurrence)
Must be flexible and able to adapt to change
Ability to manage multiple priorities effectively with excellent time management skills
Must be very detailed oriented and proficient at reviewing and editing documentation
Have a focus on professional development
Excellent written, verbal and presentation skills
Must be a team player
Proficient computer skills in MS Office applications and Internet research
Familiarity with electronic document systems
Internal Number: R22322
About Smith and Nephew, Inc.
Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients. We have leadership positions in Orthopedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:
• Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
• Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds
• Sports Medicine - minimally invasive surgery of the joint
• Trauma & Extremities - products that help repair broken bones
We have over 15,000 employees around the world. Annual sales in 2015 were more than $4.6 billion.
We are a constituent of the UK's FTSE100.