Regulatory Specialist - Randstad USA

job summary:

Job Title: Regulatory Affairs Specialist

Summary: The Regulatory Affairs Specialist develops and implements worldwide regulatory programs for marketed products and those in development. This role involves interactions with regulatory authorities to expedite approvals and participation in the development of regulatory strategies from project inception to approval, including lifecycle management of existing products. The specialist serves as a regulatory representative on cross-functional project teams, applying advanced knowledge of regulations and technical guidelines to ensure effective execution of regulatory strategies.

 
location: Telecommute
job type: Contract
work hours: 8 to 4
education: Bachelors
 
responsibilities:

Key Responsibilities:

• Develop and implement worldwide regulatory strategies for new products, medical devices, or new indications for existing products.
• Provide regulatory expertise to Research and Development to support project design and analyses.
• Collaborate with cross-functional groups to align technical activities with regulatory strategies.
• Utilize scientific training to guide experimentation scope and data selection for regulatory submissions.
• Interact with regulatory authorities on programs and initiatives that significantly impact the business.
• Advise management on regulatory aspects of product development and lifecycle management.
• Identify risk areas and develop alternative courses of action, including anticipating regulatory responses through scenario planning.
• Ensure that technical documentation for regulatory submissions meets appropriate standards and content requirements.
• Write complex scientific documents for regulatory submissions.

 
qualifications:

Job Requirements:

• Bachelor's Degree in a related scientific discipline.
• 4+ years of experience in Regulatory Affairs or related fields within the Biologics, Biotech, or Pharmaceutical industry.
• Strong knowledge of FDA and EU regulations applicable to the biotechnology and pharmaceutical industry.
• Excellent oral and written communication skills, along with critical thinking and problem-solving abilities.
• Demonstrated project management skills with the ability to evaluate complex issues and meet deadlines.
• Ability to interact effectively with regulatory officials and work within a global team framework.
• Proficient in writing comprehensive scientific information for regulatory submissions to the FDA and EU.
• Experience managing multiple complex projects and timelines in a matrix team environment.
• Strong interpersonal skills, including negotiation abilities.
• Proven ability to execute regulatory strategies through to commercialization and lifecycle management.
• Leadership skills within a matrix-driven organization, with experience bridging multiple scientific disciplines.

 
skills: FDA, Regulatory Affairs Operations

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.


Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.