What are the responsibilities and job description for the Regulatory Affairs Specialist position at The Lauridsen Group?
The Regulatory Affairs Specialist ensures compliance with applicable regulations for new and existing products. This role encompasses implementing internal organizational audits, notarizing compliance reports, and creating and managing regulatory work processes. The Specialist will remain informed about new laws and regulations, advising organizational leadership on their potential impact on the business.
This position is primarily onsite at our corporate Ankeny, Iowa headquarters with some hybrid flexibility. Successful candidate must be able to report to the office, as this is a full-time onsite role requiring in-person collaboration and engagement.
JOB QUALIFICATIONS:
Education:
Bachelor’s degree in a relevant field such as Regulatory Science, Biotechnology, Pharmacology, Quality Management, Engineering, or a related field required.
Experience:
- Minimum 3 years or more experience in Regulatory Science, nutraceutical and/or pharmaceutical industry. required.
- Industry experience with Quality Management Systems (QMS) is required.
- Familiarity with FDA filing requirements such as DMF, NDA, ANDA, MAA required.
- Experience with EU filings and procedures such (e.g. CP, DCP, MRP, NP, EDQM and CEP) is preferred.
KEY RESPONSIBILITIES
- Monitor global regulations in all regions where the company operates or distributes products.
- Ensure adherence to regulatory guidelines and standards, including cGMP, ICH, USP, ISO, GCP, and GLP.
- Collect, organize, and evaluate scientific data for regulatory submissions.
- Advise on legal and scientific requirements for global filing processes, including FDA, EU, APAC, and China.
- Prepare and submit regulatory documents to agencies and manage follow-up negotiations to secure marketing authorizations.
- Review product packaging, advertising, and marketing materials for regulatory compliance prior to commercial distribution.
- Develop and strategize plans to bring products to market while adhering to applicable regulations.
- Support internal and external regulatory audits to ensure site compliance with relevant requirements.
- Expertise in specific areas, such as MPI/OMAR, APHIS, and recombinant processes though not strictly required, would be considered a bonus.
- Assist with qualification and validation protocols.
- Perform other duties as needed to support company regulatory needs.
SKILLS:
- Strong analytical and problem-solving skills with meticulous attention to detail and a commitment to quality.
- In-depth knowledge of domestic and international regulatory frameworks.
- Excellent communication and leadership skills for effective cross-departmental collaboration.
- Proven ability to manage multiple tasks, prioritize effectively, and maintain professionalism under pressure.
- Solid understanding of ISO and GMP standards, particularly in bulk pharmaceutical production.
- Strong confidentiality, document control, and compliance skills.
Why You’ll Love Working at Proliant Health & Biologicals
At PHB, we prioritize your well-being, career growth, and work-life balance. In addition to competitive compensation, our comprehensive benefits include:
- Health & Wellness: Competitive medical, dental, and vision plans, mental health support, wellness incentives, and telemedicine options.
- Financial Security: Tuition reimbursement, 401(k) retirement match, company-paid disability and life insurance, and flexible spending accounts.
- Time to Recharge: PTO beginning at 3 weeks' per year, 9 paid holidays, and 40 hours of parental leave.
- Community Engagement: 8 hours of volunteer time off and opportunities to participate in charitable initiatives,
Join us to advance your career while making a meaningful impact in the life sciences industry!
www.phb1.com
