Director, Global Regulatory CMC Oncology Small Molecule
Site Name: USA - Massachusetts - Waltham Posted Date: Apr 5 2021 Do you want to lead a group of CMC regulatory professionals to execute regulatory strategies to help improve the lives of patients with cancer? If so, the Director, CMC Regulatory Affairs position might be for you! As Director, CMC Regulatory Affairs, you will be responsible for ensuring that GSK is executing regulatory strategies and supporting interactions with regulatory authorities appropriately. Reporting to the Sr. Director of CMC Regulatory Affairs, this position will plan and coordinate regulatory strategies necessary to support clinical development submissions (IND/IMPD and their amendments), new registrations (NDA/MA), commercialization plans, and post marketing improvements (supplements and variations) for the small molecule NME programs that meet global regulatory requirements and company business goals. Our team of passionate associates develops effective supportive care agents and therapeutics and take our responsibility to patients seriously. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Manage Regulatory CMC activities to support global expansion for key oncology products, developing strategies for appropriate filings and responses to health authority queries. Provide timely regulatory support and guidance to GSK departments, projects, and development teams with a strong emphasis on frequent interactions with technical functions Contribute to the creation and implementation of short and long term development and post-approval regulatory strategies for assigned projects and programs Contribute to the preparation and review of regulatory authority submission documents and ensure the submissions are complete, comply with applicable regulatory requirements, and are submission ready Serve as the regulatory CMC leader for assigned NME (oncology) products Drive cross functional decision making with respect to CMC regulatory issues, identifying any issues proactively and providing mitigation strategies Review technical documentation and recommend changes as appropriate to ensure regulatory compliance and conformances with existing regulatory filings and requirements Contribute to integrated product development plans to support global clinical trials and product registrations Research and analyze regulatory information and maintain current regulatory knowledge Direct and develop the regulatory staff reporting to position Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BA/BS in science discipline with at least 10 years of pharmaceutical regulatory CMC experience Experience preparing CMC sections of INDs, NDAs, and their supportive amendments and supplements (ICH Modules 2 and 3) Experience with change management processes and related regulatory requirements In-depth knowledge of the drug development process for all phases of pharmaceutical development In depth understanding of FDA guidelines and regulations, along with ICH guidance pertaining to pharmaceutical development of NMEs and maintenance of marketed products Experience preparing Quality Modules of INDs, IMPDs, NDAs, MAAs, and supportive amendments/variations Experience in both pre-approval and post-marketing applications, with a proven track-record of submissions and approvals Experience managing and supervising staff Preferred Qualifications: If you have the following characteristics, it would be a plus: Ability to influence decision-making via negotiating, advocating, and being an active listener Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting to ensure assignments are completed on-time and on-budget Strong problem-solving skills to evaluate technical information and identify appropriate regulatory strategies and actions Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions Proven ability to manage multiple projects and identify/resolve regulatory issues Excellent oral and written communication skills Effective interaction with all levels of management and departments within GSK and its business partners 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 problem solving and diplomacy 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. 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