As Associate 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 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) that meet global regulatory requirements and company business goals. Our team of passionate associates develops and will commercialize safer and more effective supportive care agents and therapeutics. We take our responsibility to patients seriously. Our team of passionate associates develops and will commercialize safer and more effective supportive care agents and therapeutics. We 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:
- 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
- Compile documentation to support the strategic management of developmental programs and commercial products
- Review technical documentation and recommend changes as appropriate to ensure regulatory compliance and conformances with existing regulatory filings and requirements
- Research and analyze regulatory information and maintain current regulatory knowledge
- Work collaboratively with GSK Quality colleagues in addressing GMP issues and supporting regulatory inspections
- Create and maintain regulatory development plan
- Contribute to integrated product development plans to support global clinical trials and product registrations
We are looking for professionals with these required skills to achieve our goals:
- BA/BS in science discipline with at least 7 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
- Experience with the drug development process for all phases of pharmaceutical development
- Experience working with FDA regulations and ICH guidance pertaining to pharmaceutical development of NME targets and marketed products
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
- Willingness to work collaboratively by incorporating diverse perspectives in order to strengthen decision-making
- Effective interaction with all levels of management and departments within GSK and its business partners
- Proactively seeks out and recommends process improvements
- 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
- Strong problem solving and diplomacy 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:
- 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
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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