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Amherst, Massachusetts, The Export Control Compliance Specialist, under the direction of the Sr. Associate Director, Research Compliance, works to implement UMass Amherst’s export control compliance program. The Export Control Compliance Specialist will analyze research projects and activities for potential intersection with U.S. export control laws and regulations (“export controls”), determine if export controls apply, and initiate appropriate action to ensure compliance. The Specialist also provides export control training to campus community members, including faculty, staff, administration, and students.    Essential Functions Analyze, interpret, and apply U.S. export controls laws and regulations, including, but not limited to, the Export Administration Regulations (“EAR,” 15 CFR Parts 730-774), International Traffic in Arms Regulations (“ITAR,” 22 CFR Parts 120-130), and sanctions programs implemented by the U.S. Treasury Department, Office of Foreign Assets Control (“OFAC”), in a university setting. Review and analyze contractual and other documents related to proposing and conducting university research to identify intersections with export controls and, when applicable, develop, implement, and document the appropriate compliance response. Coordinate and communicate with researchers to obtain information necessary to determine whether export controls apply to their research projects and convey the results of export-control compliance analyses. Conduct restricted-party screening of research collaborators and other parties, including, but not limited to, sponsors, coresearchers, primary and subcontractors, and material providers and recipients, to determine potential inclusion on restricted entity/person lists issued by governmental departments and agencies. Analyze research subject matter to determine potential inclusion on lists of export-controlled items, such as the Commerce Control List (“CCL”) and U.S. Munitions List (“USML”). Identify and apply for license and commodity jurisdiction requests to Government entities. Develop and provide export control training to campus community members, including faculty, administrators, students, and other researchers. Attend export control training sessions conducted by Government departments and agencies, including, among others, Departments of Treasury, Commerce, and State. Minimum Qualifications (Knowledge, Skills, Abilities, Education, Experience, Certifications, Licensure) Bachelor’s degree in Legal studies, Public Administration, Business, Science or engineering, or other related field and two years demonstrated experience implementing and/or enforcing federal or state regulations, preferably in the area of export controls, trade compliance, or sanctions and embargoes, though other regulatory experience may be acceptable. An equivalent combination of education, training, and experience may be substituted. Strong interpersonal and communication skills; ability to interact with a diverse client base, both in writing and orally, including students, staff, faculty and campus and system leadership; ability to deal diplomatically with people at all levels. Excellent written and oral presentation skills, including ability to create compelling presentation materials and give effective presentations. Ability to analyze complex documents and situations, identify workable solutions, and effectively balance service with regulatory compliance. Intermediate level of experience with Microsoft Word, Excel and PowerPoint. Well-developed organizational skills; ability to independently work on multiple projects concurrently and prioritize those projects. Ability to work effectively and be flexible in a fast-paced, high-volume professional environment.

Waltham, Massachusetts, We’re seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our CMC Regulatory Affairs Group supporting the GSK Strategic External Development (SED) organization. At GSK, our CMC regulatory affairs group is responsible for a portfolio of biopharmaceutical products as well as small molecule products.  This role requires you to interact across all the functions to ensure global approaches and strong connectivity. You will play a key part in GSK’s commitment to making a difference to patients’ lives enabling them to Do More, Feel Better and Live Longer. As an Associate Director CMC Regulatory Affairs, you will be based at our Waltham, MA site, however this role will interact across our global network. Reporting to the Director of CMC Regulatory Affairs, this position will plan and coordinate regulatory strategies necessary to support clinical development submissions, new registrations, and post approval submissions that meet global regulatory requirements and company business goals. The position will include projects in clinical development to study and commercialize important new COVID-19 therapies. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: You will manage, or be responsible for, the global CMC regulatory activities for assigned projects and respond readily to changing events and priorities. You will be responsible for the strategy development and creation of CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (BLA/MAA) and lifecycle management activities. You will need to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new biopharmaceutical products, to expedite the submission, review and approval of global CMC applications.    You will work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development, quality and manufacturing.  You will maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.   Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree (or equivalent) within a relevant subject such as biology, pharmacy, chemistry or a  related scientific discipline. At least 7 years of pharmaceutical company experience.   Preferred Qualifications: If you have the following characteristics, it would be a plus: Chemistry, Manufacturing and Controls (CMC) regulatory affairs or biopharmaceutical development experience with direct involvement in regulatory submission preparation across all stages of development. Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development. Detailed knowledge of the drug development and manufacturing and supply processes Understanding of FDA regulations and ICH guidance pertaining to pharmaceutical development of NMEs and marketed products Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines. Excellent verbal and written communication skills. Ability to work independently with minimal supervision as well as in a team environment The ability to successfully influence and negotiate issues at the appropriate level within your organization and/or with regulatory agencies in a variety of settings. Strong problem-solving skills to evaluate technical information and identify appropriate regulatory strategies and actions.  Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy. Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives. Experience of Agency interactions and/or submissions in US, EU, Japan and China. Resourceful, creative, enthusiastic, and results-oriented Self-motivated, assertive, self-confident and acts with a sense of urgency and passion Proven ability to work with a high level of integrity, accuracy, and attention to detail Strong interpersonal skills   Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:   Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness.  

Waltham, Massachusetts,     We’re seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our CMC Regulatory Affairs Group supporting the GSK Strategic External Development (SED) organization. At GSK, our CMC regulatory affairs group is responsible for a portfolio of biopharmaceutical products as well as small molecule products. This role requires you to interact across all the functions to ensure global approaches and strong connectivity. You will play a key part in GSK’s commitment to making a difference to patients’ lives enabling them to Do More, Feel Better and Live Longer. This role will be based at our Waltham, MA site, however this role will interact across our global network. Reporting to the Director of CMC Regulatory Affairs, this position will plan and coordinate regulatory strategies necessary to support clinical development submissions, new registrations, and post approval submissions that meet global regulatory requirements and company business goals. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… You will manage, or be responsible for, the global CMC regulatory activities for assigned projects and respond readily to changing events and priorities. You will be responsible for the strategy development and creation of CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (BLA/MAA) and lifecycle management activities. You will need to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new biopharmaceutical products, to expedite the submission, review and approval of global CMC applications.    You will work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development, quality and manufacturing.  You will maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.   Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor degree (or equivalent) within a relevant subject such as biology, pharmacy, chemistry or a related scientific discipline. At least 5 years of pharmaceutical company experience.       Preferred Qualifications: If you have the following characteristics, it would be a plus: Ability to work independently with minimal supervision as well as in a team environment The ability to successfully influence and negotiate issues at the appropriate level within your organisation and/or with regulatory agencies. Problem-solving skills to evaluate technical information and identify appropriate regulatory strategies and actions.  Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy. Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives. Experience of Agency interactions and/or submissions in US, EU, Japan and China. Self-motivated, assertive, self-confident and acts with a sense of urgency and passion Proven ability to work with a high level of integrity, accuracy, and attention to detail Chemistry, Manufacturing and Controls (CMC) regulatory affairs or biopharmaceutical development experience with direct involvement in regulatory submission preparation. Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development. Knowledge of the drug development and manufacturing and supply processes Understanding of FDA regulations and ICH guidance pertaining to pharmaceutical development of NMEs and marketed products Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.   Why GSK? Our values and expectations  are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness.