As the Manager of Regulatory Affairs, this role advises the research, creative, application and commercial departments or customers on the safe use, regulatory compliance, regulatory strategy or advocacy for ingredients and products. This may include the execution of regulatory compliance reviews, the preparation of various documents supporting the regulatory compliance o

As the Associate Manager of Regulatory Affairs, this role advises the research, creative, application and commercial departments or customers on the safe use, regulatory compliance, regulatory strategy or advocacy for ingredients and products. This may include the execution of regulatory compliance reviews, the preparation of various documents supporting the regulatory co

Analyze FDA regulatory requirements for all pharmaceutical dosage forms, applying Analytical method development and validation, USP/NF, 21 CFRs FDA guidelines; Plan, prepare for, and manage all regulatory submissions, including CTD/eCTD (Electronic Common Technical Documents), NDA, and ANDA; Perform regulatory risk assessment and provide regulatory input to the CEO and ex

The Senior Director, Regulatory Affairs CMC, is responsible for providing strategic leadership and oversight in regulatory Chemistry, Manufacturing and Control (CMC) for primarily PTC pharmaceutical/small molecule development products. This involves but not limited to leading development and implementation of robust global regulatory CMC strategy that is phase appropriate

Ability to anticipate problems relating to projects and to develop and implement solutions. Excellent interpersonal skills. Fluent knowledge of written and verbal English. Highly organized and result oriented. Ability to work independently as well as in a team environment. Proficient knowledge of Microsoft Office packages including but not limited to Word and Excel. What

Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas SBSE Small Business/Self Employed, SB/SE Deputy Commissioner Exam, Specialty Examination, Estate & Gift /Excise Tax Exam The following are the duties of this position at the full working level. If this vaca

Job Title Senior Regulatory Operations Specialist About this role The Senior Regulatory Operations Specialist position is an integral part of MRM for Health and the Regulatory Operations capability. Regulatory Operations is accountable and responsible for the preparation, review, and submission of regulatory packages to Client Medical, Legal and Regulatory (MLR) groups. T

OF POSITION Plans, coordinates, authors and critically reviews submissions to FDA ensuring that internal consistency and consistency to relevant FDA guidelines are met. Submissions will include Original 505(b)(2)s, pINDs, INDs, Meeting requests, ANDAs , Amendments, Supplements, Annual Reports, and other life cycle management activities. Works with project management, devel

Prepares /oversees the preparation of various regulatory submissions including Pre Submissions, 510(k) submissions, CLIA Waiver Applications, Dual 510(k)/Waiver by Applications, technical files, and license applications. Monitors new and changing regulations and guidance and disseminates information to stakeholders. Identifies regulatory trends and conducts key regulatory

The Master Data Governance and Maintenance Manager is responsible for driving the business strategy by ensuring the creation, maintenance, and monitoring of high quality, reliable master data. This role is pivotal in establishing a culture where master data is inherently trusted, facilitating seamless business transactions, informed decision making, and operational excell

Manage Regulatory Affairs, Advertising & Promotion and Compliance Group Manage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motivate line reports to achieve shared and individual goals. Regulatory Leadership of Advertising and Promotional Materials Serve as subject matter

A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and owner

Develop solutions to improve processes for global regulatory submissions. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking and documentation for submissions Manage Regulatory tools/database and new enhancements. Interact with global regulatory leaders and peers to share and manage department metrics a

Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

The Real World Evidence (RWE) Regulatory Lead will provide regulatory advice and consultation to Syneos Health's Real World and Late Phase (RWLP) opportunities and programs. Increasing interest from regulators to realize the full potential of fit for purpose real world data (RWD) to generate real world evidence (RWE) that will advance therapeutic product development and o