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Regulatory Specialist, R&D
2 months ago
Regulatory Specialist, R&D
W2 Contract
Pay Rate: $35 - $40 per hour
Location: San Diego, CA - Remote Role
Job Summary:
As a Regulatory Specialist, you will implement worldwide regulatory programs for developing and marketed products and interact with regulatory authorities to expedite approvals. This role is part-time, remote, and 20 hours per week. We need someone who can be flexible with the days and times of work to meet the needs of the company and regulatory agencies.
Duties and Responsibilities:
- Help develop and execute regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products.
- Serve as a regulatory representative on cross-functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to ensure execution of regulatory strategies and requirements.
- Provide regulatory expertise to R&D to support the design and analyses of projects and interact with cross-functional groups to ensure the alignment of technical activities and regulatory strategies.
- Utilize scientific training when interfacing with the management of technical areas and project teams to guide the scope of experimentation and the data selection needed to support regulatory submissions.
- Interact with regulatory authorities regarding programs and initiatives that impact the business.
- Advise management on regulatory aspects of product development/lifecycle management.
- Identify risk areas and develop alternative courses of action, including anticipating regulator responses through scenario planning and contingency plans.
- Ensure that technical documentation for regulatory submissions meets the appropriate standards and content requirements, including planning and implementation around emerging and changing regulatory requirements.
- Write documents with complex scientific information for regulatory submissions.
Requirements and Qualifications:
- Bachelor's degree in a related scientific discipline
- 4+ years of experience in Regulatory Affairs or related fields within the Biologics, Biotech, or Pharma
- Knowledge and understanding of FDA and EU regulations for the biotechnology and pharmaceutical industry and global regulatory regulations
- Demonstrated project management skills and ability to interact with regulatory officials.
- Able to evaluate complex issues and meet deadlines to ensure compliance and business timelines to accomplish company objectives.
- Able to work within a global team framework and multi-cultural environment.
- Can write comprehensive scientific information for regulatory submissions to the FDA and EU; demonstrated interpersonal skills, including negotiation.
- Able to manage multiple complex projects and timelines in a matrix team environment.
- Able to execute regulatory strategies to commercialization. Prior experience in bridging several scientific disciplines.
Desired Skills and Experience
Regulatory Affairs, biologics, biotechnology, pharmaceutical, regulatory submission, FDA, EU
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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