Manager, Regulatory Salary at Bloomberg Lp BETA

Job Description Responsible for managing Regulatory Publishing staff who format and publish electronic documents, build Regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs, including their amendments and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). Job Duties •Manages staff who electronically format, publish electronic documents and builds Regulatory submission deliverables. Ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures. •Provides guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc) •Provides guidance on good documentation and submission practices •Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing stand

Job Title: Senior Manager, Regulatory Strategy Location: Azusa, CA Position Type: Full-time Exciting opportunity to join a dynamic and innovative Cosmetics company - the team is committed to excellence and continuous improvement in all aspects of the business, but most importantly QC/Regulatory. As the team expands operations, they seek a highly qualified and experienced Senior Manager, Regulatory Strategy to join the team. Job Summary: The Senior Manager, Regulatory Strategy will play a crucial role in ensuring our compliance with regulatory requirements, optimizing our product development processes, and guiding strategic decision-making. Reporting to the VP of QC/Regulatory Affairs, this position requires a candidate with strong leadership skills, a deep understanding of regulatory frameworks, and the ability to collaborate cross-functionally to achieve regulatory compliance objectives. Key Responsibilities: Regulatory Strategy Development: Develop and implement comprehensive regulat

Our client, a leading global medical device company is seeking a Senior Manager Regulatory Affairs to join their division on-site in their downtown Atlanta office. This new team member is responsible for the management and leadership of the Regulatory Affairs department. The manager is responsible for allocating and managing department resources to accomplish department and corporate objectives. Responsibilities: Recruits, coaches and develops organizational talent. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Creates an entrepreneurial environment. Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May manage and coach a team of regulatory employees. Keeps the organization's vision and values at the forefront of decision making and action. Demonstrates effective change leadership. Builds strateg

Job Description Hilltop Holdings is looking to hire a Regulatory Reporting Manager. The Regulatory Reporting Manager is considered an experienced professional responsible for producing and submitting multiple regulatory filings in compliance with legal and regulatory requirements, the organization's policies and procedures, and accepted accounting principles. This position will prepare reports for bank and bank holding companies' regulatory agencies, focusing on quarterly Call and FRY-9C reports and other regulatory submissions. The position will have an elevated level of visibility within the organization with opportunities to work directly regularly with Management and will also interact very closely with other groups throughout Hilltop, including Risk, Legal, Treasury, Accounting, SEC Reporting, and Accounting Policy. Other responsibilities include various support tasks associated with earnings release, 10-Q/10-K disclosures, internal controls on Regulatory data integrity, data qual

This is a new hire for a company who has over 10 years experience in Biologics focusing on producing therapies using antibodies. Looking at Oncology, Infectious Disease and Haematology, this company strives to offer the best antibody based medicine to patients globally. They are hiring for an experienced CMC Regulatory Affairs Senior Manager. The candidate who would fit this role would be someone skilled in the below: CMC specialist in Drug Product development and manufacturing of injectable biologics (e.g., vials, prefilled syringes, auto injectors). Lead US (BLA) & EU (MAA) CMC strategy & authoring for drug development through to commercialization worldwide. Lead engagement with regulatory agencies and commercial partners.

About the job Senior Manager Regulatory Affairs Senior Manager Regulatory Affairs A well-known large consumer products corporation is hiring for Regulatory Affairs Manager. Responsibilities include: Ensure completion of appropriate documents during the development life cycle and launch Ensure compliances with policies and product regulations Ensure compliances with standardization of consumer communications Responsible for all US regulatory submissions, supplement notifications, and application of any changes in the regulations for submissions Requirements Atleast 4-5 years relevant experience Degree in Science Product development experience strongly preferred If you are interested in the above opportunity please apply. Only relevant candidates will be contacted. workforcesolutionsvirensglobal... Locations: America, Europe, Asia & Australia

This is a new hire for a company who has over 10 years experience in Biologics focusing on producing therapies using antibodies. Looking at Oncology, Infectious Disease and Haematology, this company strives to offer the best antibody based medicine to patients globally. They are hiring for an experienced CMC Regulatory Affairs Senior Manager. The candidate who would fit this role would be someone skilled in the below: CMC specialist in Drug Product development and manufacturing of injectable biologics (e.g., vials, prefilled syringes, auto injectors). Lead US (BLA) & EU (MAA) CMC strategy & authoring for drug development through to commercialization worldwide. Lead engagement with regulatory agencies and commercial partners.

Job Description Job Description SUMMARY OF POSITION Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Plans, coordinates, authors and critically reviews submissions to FDA ensuring that internal consistency and consistency to relevant FDA guidelines are met. Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files. Ensures that all due dates for regulatory milestones, in support of both pre and post-approval submissions, are met. Works on and solves increasingly complex projects/problems where analysis of the situation or data requires evaluation of some intangible factors. Ensures that regulatory files and data systems are maintained and in compliance with related work instruc