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Director of Regulatory Affairs
For over 14 years, Spectrum Solutions has been a single-source provider of high-quality consumer product innovation providing customers measurable process optimization, unmatched scalability, and overall cost savings. With full-service on-site manufacturing, custom packaging, kitting, fulfillment, and global logistics, our technology, products, and services provide the industry with full product development-to-delivery solutions.
Our commitment and mission are to: “Build the best products. Champion the simplest solutions. Deliver as promised”. At Spectrum we believe that opportunities and creativity pave the way to innovation. Here your passion, resourcefulness, and perseverance will do more than just join something, they will add something.
We are looking for a Director of Regulatory Affairs to work in our Draper, UT location to serve as a collaborative leader in charge of developing an effective regulatory strategy that includes a clearly defined regulatory path through the product lifecycle from the beginning of the idea to post approval, and market release. This person is responsible of representing company when it comes to developing and maintaining a positive working relationship with primary regulators such as the FDA, and leading the preparation and submission of all the necessary regulatory documents for certifications such as 510ks, etc.
The ideal candidate will be an excellent communicator and team player, who has the ability to take charge and lead the company in all the regulatory affairs activities.
- Collaborate with the executive team to lead the development of regulatory strategies and objectives that result in the correct registration, successful approval, and commercialization of products.
- Proactively provide strategic and tactical regulatory guidance on complex development matters to multidisciplinary teams ensuring regulatory activities are in alignment with goals and objectives.
- Plan, manage and assign resources to maintain submission deadlines
- Maintain strategic communication with regulatory authorities for strategic related to projects/product submissions.
- Stay up to date with current regulatory updates, to assess any potential impact, and to implement changes accordingly.
- Responsible for creating and maintaining product documents, development plans, as well as non-clinical and clinical protocols and reports.
- Partner with and support the research and development team with the development of the product life cycle, this may include helping with preclinical studies and documentation, the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures.
- Be able to analyze complex situations and develop a strategy for company programs with appropriate risk mitigation strategies.
Requirements and Qualifications
- Experience with preparation and submission of regulatory filings (i.e. original ANDAs, amendments/supplements, annual reports, etc.) and thorough knowledge of regulations relevant to pharmaceutical manufacturing is required.
- Knowledge and experience with cGMP, QA/QC fundamentals, SOP, Manufacturing, OSHA and DEP/EPA as they relate to the medical, and pharmaceutical industry is required.
- Excellent listening and verbal/written communication skills, to include public speaking, are required.
- Agility in effective decision-making and negotiation is required.
- Ability to coach and develop team members is also required.
- Be able to sit for long periods of time, and stare a computer screen.
- Bachelor’s Degree in scientific discipline or related field. An advanced degree is preferred.
- 10 to 15 years of experience working in a regulated environment with at least 10 years direct regulatory affairs experience is required.
- Regulatory Affairs Certification (RAC) is a plus.
- Leadership Training, GMP Compliance Auditing training, etc. is preferred.
- To be successful in this position you must be able to use Microsoft Office programs (word, excel, etc).
Job posted: 2022-01-01