Senior Regulatory Affairs Specialist

Enter Job Description...

• Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
• Regulatory support for integration activities including reviews of product labeling and marketing materials for accuracy and compliance with regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.
• Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
• Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk.
• Responds to customers' and/or authorities' requests/inquiries dealing with regulations and product compliance.
• Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level.

The Ideal Candidate will have:

• Bachelor's or master's Degree or equivalent.
• Regulatory experience in a highly regulated industry such as pharmaceuticals or diagnostics
• Typically, at least 4+ years relevant experience for entry into this level.
• Post-graduate certification and/or license may be required.

EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.