Director, Regulatory Affairs Salary at Almatica Pharma Llc BETA

Support the Global Therapeutic Area Lead (GTAL), Regulatory Affairs (Senior Director) in developing and executing regulatory strategies for antimicrobial/ antifungal programs globally or within specific regions Focused on Lifecycle Management, rather than development phase. SPECIFIC TASKS Assisting in preparing presentations, reports, and strategic documents for leadership discussions. Maintaining and tracking project timelines, action items, and regulatory deliverables to ensure smooth execution. Organizing and documenting meeting minutes and action items to support the leader’s strategic planning. Contribute to the preparation and submission of regulatory documents related to antimicrobial/ antifungal programs to regulatory authorities. Conducting research on regulatory trends, competitor strategies, and market intelligence to provide background insights. Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies and Submissions with Global Development Pl

Position Title: Director, Regulatory, CMC Reports to: ED, Regulatory Affairs Location: Hybrid, Princeton, NJ PMV is seeking an experienced and motivated Director of Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) to lead the development and execution of CMC regulatory strategy for the Company’s assets. The Director, Regulatory Affairs-CMC will work closely with cross-functional teams, including other Regulatory functions, CMC, Quality Assurance, and external vendors) to ensure the successful submission of CMC dossiers and compliance with regulatory guidelines across regions throughout the product lifecycle. Responsibilities Act as Regulatory CMC Lead: Serve as the primary interface between CMC subject matter experts (SMEs) and Regulatory Affairs. Coordinate and lead all CMC regulatory projects, including budget, timelines, and CMC submission planning, ensuring all deliverables are met on time and within scope. Manage Regulatory CMC contractors/consultants to ensure acti

Support the Global Therapeutic Area Lead (GTAL), Regulatory Affairs (Senior Director) in developing and executing regulatory strategies for antimicrobial/ antifungal programs globally or within specific regions SPECIFIC TASKS Assisting in preparing presentations, reports, and strategic documents for leadership discussions. Maintaining and tracking project timelines, action items, and regulatory deliverables to ensure smooth execution. Organizing and documenting meeting minutes and action items to support the leader’s strategic planning. Contribute to the preparation and submission of regulatory documents related to antimicrobial/ antifungal programs to regulatory authorities. Conducting research on regulatory trends, competitor strategies, and market intelligence to provide background insights. Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies and Submissions with Global Development Plans and Regulatory Strategy Plans SPECIFIC TASKS Maintaining cen

Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The candidate will manage and lead regulatory submission-related activities associated with the US and ex-US fillings for assigned products, ensure timelines are appropriately managed and met, and issues are appropriately raised and resolved in a timely manner. Represent regulatory affairs on assigned project teams and support R&D and clinical research activities. Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. Provide oversight of regulatory consultants and vendors where applicable. Provides regulatory strategic support and guidance to project teams. Mentor and management of direct reports. Performs research on regulatory precedence and competitive intelligence as needed. Contributes to iden

MUST HAVEAt least 8+ years strategy level experience Only US (FDA) experience is relevant Experience being the Lead point of contact for FDA 8+ branded drug experience (NOT generics) Able to work onsite 50% Overview: The Associate Director/Director, Regulatory Affairs - Global Development Products (Anti-Viral), provides essential support to the Executive Director in overseeing regulatory activities related to antiviral initiatives on a regional and/or global scale. This role involves assisting in the development and execution of regulatory strategies, regulatory submissions, and fostering collaboration with regional regulatory authorities. The Associate Director will work closely with cross-functional teams to integrate antiviral considerations into product development, manufacturing, and commercialization processes. This position plays a pivotal role in ensuring alignment with company goals, regional requirements, and best practices to achieve successful outcomes for our antiviral ini

Job Title: Head of Regulatory AffairsJob Description We are seeking a Head of Regulatory Affairs to be based in Bridgewater, NJ. Reporting to the Chief Scientific Officer, this position will lead our regulatory submissions as well as preside over the companys regulatory strategy. The position will lead the regulatory affairs and operations team and partner closely with the R&D, Technical Operations, and clinical development teams, along with external consultants. The Head of Regulatory Affairs will be a key member of management and product development leadership teams, guiding the strategic direction of development programs to meet regulatory approval standards on both US and global bases. Responsibilities + Lead, manage, and coordinate regulatory activities for the companys portfolio in collaboration with the R&D, Technical Operations, Clinical Development, Program Management, Manufacturing, Business, and Commercial teams. + Develop and implement a regulatory strategy for pipeline pro

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is responsible for the management of global regulatory leads with product and disease state expertise for specific therapeutic area(s). Provides oversight for the development and implementation of global strategies, ensuring legislation requirements are met. Provides oversight on strategic regulatory decisions and ensures regulatory and cross-functional alignment. Provides oversight

Job Description Job Description SUMMARY OF POSITION The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client’s ’s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment. Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. Provides sound regulatory strategies in support of complex issues where analysis of “de novo” situations requires an evaluation of intangible factors. Continually monitors newly published FDA guidelines in the context of new and ongoing development programs and will provide training on applicable requirements for regulatory and scientific staff as required. Collaborates with functional groups to plan, author, compile and submit high-quality original app