Associate Director/Manager, Chemistry Manufacturing and Controls (CMC) Technical Writing
Site Name: USA - Massachusetts - Waltham, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence Posted Date: Sep 30 2021 Are you interested in developing and commercializing safer and more effective supportive care agents and therapeutics? If so, the Associate Director, Chemistry Manufacturing and Controls (CMC) Regulatory Affairs Writing position might be for you. As an Associate Director, you will ensure that GSK is executing regulatory strategies and supporting interactions with regulatory authorities appropriately. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Develop and lead the execution of submission plans. Consult on and be accountable for the execution of timely and innovative regulatory strategies in support of global development and life cycle management of assigned projects Collaborate with Global RA CMC lead and/or Regional RA CMC lead to provide regulatory support for assigned projects Contribute to the evaluation of the impact of changes to the regulatory landscape Collaborate with Regulatory Operations for the preparation of global clinical trial applications, marketing applications and post-approval supplements and variations Contribute strategically to the development of and to the definition of the CMC content requirements for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, BLA, MAA) Plan and manage resource needs for authoring, review and approval of submission-ready documents for a projects Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations Review submission documents to ensure messaging and content is clear and consistent within and across documents Research and analyze regulatory information and maintain current regulatory knowledge Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data into CMC documents intended for submissions to Global Health Authorities using templates and style guide. Develop regulatory processes and procedures to support company growth Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BA/BS in scientific or technical discipline At least 8+ years of biopharmaceutical regulatory experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree Experience preparing CMC sections of INDs, IMPDs, BLAs, MAAs, and supportive amendments and supplements (ICH Modules 2 and/or 3) Project management experience. Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance Thorough understanding of FDA regulations and ICH guidance pertaining to pharmaceutical development of NME targets and marketed products Thorough understanding of change management processes and regulatory requirements Exposure to regulatory requirements for biologic product development is highly desired Proven ability to work with a high level of integrity, accuracy, and attention to detail Strong problem-solving skills to evaluate technical information and identify appropriate regulatory actions with limited supervision Self-motivated, assertive, and self-confident with the ability to act with a sense of urgency and passion 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 a sense of urgency to ensure assignments are completed on-time and on-budget with a high level of quality Ability to manage contributors that work independently with minimal supervision and to foster a team environment Ability to make timely and meaningful decisions and take corresponding actions Willingness to work collaboratively by incorporating diverse perspectives and in order to strengthen decision-making Proactively identifies and implements process improvements Entrepreneurial, enjoys working in a fast-paced, small-company environment Proven ability to manage multiple projects, identify and resolve regulatory issues Ability to balance regulatory objectives with business objectives Ability to influence the regulatory team in a positive way Ability to take disparate inputs and drive them into one cohesive strategic regulatory decision Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company Resourceful, creative, enthusiastic, and results-oriented Strong interpersonal skills and the ability to effectively work with other departments and vendors Positive and energetic attitude 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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