Our company has several public companies in our control and one of which, we have structured the re-org and all associated resources to bring the company current, including two years of filings to the sec and any/all regulatory agencies. The group® has positioned all the resources including preparation of all financials for audits and filings upon receipt of funds and we are well versed in the otcmarkets to accomplish the task.
The opportunity is to loan/fund/partner with the group®, and provide, $65k to bring the company current with all regulatory agencies filings and two years of audited financials. At this point we would file a 15c211, however, if pubco had an intended target, then we could file two years of the private company’s financials, w/w.O audits with the 15c211 which would expedite and, simplify the process including the economics. Once current with the sec the shell is worth ~$400,000
we can provide the majority share control block of the public company as collateral. Also, we would entertain having an equity partner as well.+1 Other Responses
Clinical Regulatory Affairs In California
This is a new opportunity for a senior manager / associate director, regulatory affairs (clinical) full-time position in california.
manage and lead regulatory activities for assigned programs to ensure alignment and compliance with local, federal, and other regional registration requirements, as well as with company policies.
At the senior manager level, implement plans for timely submission and approval of preclinical submissions, applications for clinical trials, marketing applications, etc, and provide regulatory guidance and support to project teams. The senior manager may provide guidance to members of the regulatory team.
At the associate director level, the incumbent will develop and implement regulatory strategies for timely submission and approval of preclinical submissions, applications for clinical trials, and marketing applications, and provide regulatory leadership to project teams. The associate director will possess the regulatory expertise to translate regulatory requirements into practical, workable plans and interact with regulatory agencies.
-partner with project leaders, department heads, and project teams to collaboratively implement the company’s regulatory strategies.
-the associate director level incumbent will provide strategic input and function as the regulatory lead on project teams, and will provide guidance/advice to the project leader and team on regulatory matters.
-provide us, eu, and/or global operational input and coordination of regulatory strategies.
-manage the assembly, review, and approval of assigned regulatory dossiers and documents (content) and the final sign-off of regulatory submissions.
-provide input to target labeling content (mds, smpc, us package insert, container packaging, etc).
-manage the regulatory work of cros and consultants.
-a ba/bs with 6+ years’ clinical regulatory affairs experience, with 2 years in a management role. The associate director level will have 8+ years’ experience and 3+ years’ management experience with lead clinical regulatory responsibilities.
-broad to in-depth understanding of fda drug and biologic regulations and guidelines, particularly clinical development.
-previous experience working with cder and/or cber, some aplb/ddmac exposure desirable.
-experience and knowledge in the preparation and submission of major regulatory submissions, supportive amendments, and supplements.
-experience interfacing with relevant regulatory authorities highly preferred.
-experience in project team management.
-fluent knowledge of all stages of pharmaceutical drug development with emphasis in clinical development and operations compliance and documentation.
Contact us here on zintro for more details.+11 Other Responses