As a CMC Regulatory Project Manager, 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.
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements. The information that you have provided in your cover letter and CV will be used to assess your application.
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 3 years of pharmaceutical company experience.
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.
- 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, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
- Strong 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.
- Good 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
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:
- Support decision making using evidence and applying judgement to balance pace, rigour and risk.
- Be committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Sustain energy and well-being, contributing to building resilience in teams.
- Continuously look for opportunities to learn, build skills and share learning both internally and externally.
- Translate strategy into action - a compelling narrative, setting objectives and motivating others.
- Build strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
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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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