Director, Regulatory Affairs Salary at American International Chemical Llc BETA

Sentec seeks an energetic and seasoned Senior Manager of North American Regulatory Affairs to lead North-American Regulatory Affairs for our portfolio of products in the United States and Canada. This position reports to the Global Head of Regulatory Affairs and Quality Assurance. Candidates should be versatile, self-driven individuals with a passion for patient care and strategic contribution in a small company environment. This position will work closely in conjunction with, and as an extension of, the Sentec AG Regulatory Affairs team based in Switzerland. This position is based in our Lincoln, Rhode Island office. Key Tasks: External focus Develop regulatory strategy for product clearances in conjunction with Sentec AG’s regulatory team. Compile submission dossiers for new product and changes to existing approvals in close cooperation with internal and external stakeholders (e.g. regulatory consultants). Lead FDA pre-submission, de-novo, breakthrough, pre-market authorization or si

Have you ever felt blown away by the miracles of modern medicine, while also feeling that the patient experience still leaves much to be desired? Here at Myomo, Inc., it's our mission not only to leverage the power of cutting-edge robotic technology to improve patient quality of life, but also to demonstrate a commitment to prioritize and serve the patient. We are 1st in the U.S. to develop and market the MyoPro® product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in the paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord or nerve injury such as brachial plexus injury, or other neuromuscular disability such as traumatic brain injury, (TBI) brachial plexus injury, (BPI) or multiple sclerosis (MS). It is the only device that, sensing a patient’s own neurological signals through non-invasive sensors on the arm, can restore their ability to use their arms and hands so that they can return to work, live indepe

Senior Director of Regulatory Affairs CMC / Head of Reg CMC MA based - 2 days in the office (not rigid) Are you ready to lead regulatory CMC strategies for innovative therapies? Join a dynamic biopharmaceutical team tackling rare disease. About the Role As Senior Director of Regulatory Affairs CMC/Head of RA CMC, reporting to the Head of RA , you’ll drive global CMC regulatory strategies, ensuring clinical and market access for cutting-edge products. From submission leadership to compliance oversight, your expertise will guide key development phases and life cycle management. Key Responsibilities Develop and execute domestic/global RA CMC strategies and submissions. Lead preparation of CMC content for INDs/IMPDs/CTAs, and NDAs/MAAs. Collaborate with global health authorities and manage regulatory interactions. Monitor FDA/ICH guidelines and share insights with internal teams. What You’ll Need 10+ years in RA CMC with a focus on small molecule drug development; rare disease experience a

Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization. You will also communicate and negotiate with international

About us: Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology. Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated therapies at a fast pace. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses. Position overview: The Director of Regulatory Affairs will report to the SVP of Regulatory and Quality. The individual in this role is responsible for developing and implementing regulatory strategies, interfacing with regulatory agencies, identifying and managing regulatory risks, implementing the regu

This biopharmaceutical company is developing and commercializing an innovative pipeline of cancer therapies and immunology treatments. They are seeking a Regulatory Affairs Senior Director who can develop and implement global regulatory strategies for an approved immunology product and support their portfolio of oncology programs. Reporting into the SVP of Regulatory & Quality, you will manage assets through all phases of development and work closely with Health Authorities. This company offers flexible work arrangements, a strong cash position, and a collaborative company culture. With two approved products and an innovative pipeline, now is an exciting time to join this growing organization! Responsibilities: Serve as Global Regulatory Lead for an approved immunology product and support a portfolio of oncology programs. Ensure the development and execution of regulatory strategies for the assigned products/projects. Serve as a strategic partner for internal cross functional stakehold

Vice President, Oncology TA R&D Head Lead BOTH Drug Discovery and Clinical Research - team of ~50 people Unique and attractive company culture Retained Search Cornerstone Search Group is pleased to have been retained again by a profitable $1.5Bn+, high-market cap, fully integrated, oncology-focused pharma with a uniquely positive work environment that reflects its European HQ country’s renowned culture. With a product portfolio featuring a current oncology blockbuster and the upcoming launch of another anticipated oncology blockbuster, our client is in a very active phase of building out their pipeline through both extensive in-house research across multiple modalities (ADC / bsAb / small molecule) and in-licensing efforts. This unique VP-level leadership role is responsible for Oncology R&D strategy and execution across both drug discovery and clinical development. Our client is seeking an entrepreneurial MD or MD/PhD who is presently a Senior Director (or higher) in the pharma indust

Are you curious about solving complex business challenges for a leading convenience retailer? Do you have a passion for cross functional collaboration? Then you may be the perfect addition to our team! EG America is one of the fastest-growing convenience store retailers in the United States, committed to becoming America’s #1 ‘one-stop’ destination. The business has an established pedigree of delivering excellent fuel, grocery and merchandise, and food service. Headquartered in Westborough, Massachusetts, our Company has grown to over 1,500+ locations across the United States employing over 18,000 team members. You can find us operating under the following store banners: Certified Oil, Cumberland Farms, Fastrac, Kwik Shop, Loaf N Jug, Minit Mart, Sprint Food Stores, Tom Thumb, Turkey Hill, and Quik Stop. Our headquarters in Westborough, MA is home to our Store Support Center, Company Warehouse, and Culinary Center. What We Offer: Competitive Wages Work today, get paid tomorrow through