Regulatory Affairs Coordinator Salary in Boston, Massachusetts

Company DescriptionAbbVie'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 DescriptionWe're seeking a Quality Assurance Manager to ensure compliance and efficiency in our quality system for drug, biologics, device, and/or combination products. You'll lead cross-functional teams, design effective quality systems, and coordinate interrelated function activities. You'll support the introduction of new products, identify potential gaps, and oversee training programs. If you're a detail-oriented professional with a strong background in qual

Recent Pharma/ CRO experience required Regulatory Operations Contractor Regulatory Affairs Location(Boston) Contract Term: Contract through EOY with possible extension Should have strong Word, PDF, Adobe skills going through documentation, cleaning it up, getting approvals, submissions, sending out to Reg Document publishing is key, submission publishing with document publishing is even better Supported preparation of NDA and created project plans for NDA modules Extensive bookmarking and hyperlinking, taking all the submission documents and hyperlinking all the supporting study data and reports. Position Summary: Reporting to the Senior Director, Regulatory Operations, the Regulatory Operations Contractor will assist with the development and implementation of systems and procedures used to support regulatory submission activities including eCTD production, document publishing, and document management. This position will also be responsible for participating in day-to-day Regulatory Op

Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the body including the airway, which can be life-threatening. We have a culture built on the core values of caring, trust, diversity and freedom and is driven by individuals committed to developing breakthrough therapies that have real impact on people’s lives. If you are looking for a place where your work can have meaning and you can make a difference – Pharvaris is the place for you. We are now looking for a highly driven Manager, Regulatory Affairs to join and help implement our RA strategy and priorities. If you are an innovative and pragmatic RA professional - inspired by building effective solutions and passionate about balancing p

The ideal candidate should have US Advertising and Promotion experience. This position can be fully remote. PURPOSE AND SCOPE: Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for assigned projects. Prepares for agency interactions by writing and organizing associated documentation, including letters and briefing packages. Reviews and advises on manufacturing and control changes for marketed products, labels and clinical materials for products in development. PRINCIPAL DUTIES AND RESPONSIBILITIES: Provides regulatory assessment and support. Evaluates and assesses regulatory impact of proposed product changes. Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development teams. Provides proje

Recent Pharma/ CRO experience required Regulatory Operations Contractor Regulatory Affairs Location(Boston) Contract Term: Contract through EOY with possible extension Should have strong Word, PDF, Adobe skills – going through documentation, cleaning it up, getting approvals, submissions, sending out to Reg Document publishing is key, submission publishing with document publishing is even better Supported preparation of NDA and created project plans for NDA modules Extensive bookmarking and hyperlinking, taking all the submission documents and hyperlinking all the supporting study data and reports. Position Summary: Reporting to the Senior Director, Regulatory Operations, the Regulatory Operations Contractor will assist with the development and implementation of systems and procedures used to support regulatory submission activities including eCTD production, document publishing, and document management. This position will also be responsible for participating in day-to-day Regulatory

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 We're seeking a Quality Assurance Manager to ensure compliance and efficiency in our quality system for drug, biologics, device, and/or combination products. You'll lead cross-functional teams, design effective quality systems, and coordinate interrelated function activities. You'll support the introduction of new products, identify potential gaps, and oversee training programs. If you're a detail-oriented professional with a strong background in q