Senior Manager, Global Regulatory Affairs
- Rockville, MD
Site Name: USA - Maryland - Rockville
Posted Date: Oct 29 2020
Are you interested in providing input while managing regulatory activities for life-cycle assets to facilitate patients access? If so, GSK's Rockville Slaoui Center for Vaccines Research (SCVR) Senior Manager, Global Regulatory Affairs role could be an ideal opportunity to explore.
As a Senior Manager, Global Regulatory Affairs you will be responsible for regulatory submissions, interactions, and strategy related to established/licensed vaccines, primarily (but not exclusively) in the US. The role interfaces proactively and seamlessly with the Global Regulatory Lead for the assigned products to provide strategic advice and execution of deliverables for US submissions and FDA interactions. You will contribute into the content of or lead preparation/authoring of relevant sections of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations, Paediatric Investigational/Study Plans, etc.) whiling ensuring that these documents meet high scientific standards and regulatory requirements.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :
- Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.
- Provide input into the asset specific regulatory strategy on a global scale.
- Interact with (or represents his/her area/product at) internal project related teams and provide in-depth strategic, scientific and RA input, for all parts of RA aspects of a given project on technical, nonclinical, clinical or procedural aspects.
- Provide support to the GRL via authoring, input and/or critical review of one or more specific sections (technical/nonclinical/clinical and/or procedural) of regulatory documents, Global Regulatory Plan(s) and/or Key Message Summaries.
- Provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of clinical/labelling strategy and use of appropriate regulatory procedures to secure the optimum submission strategy; contribute or lead preparation of sub-sections related to clinical/labelling.
- Provide input into and lead preparation/authoring of one or more specific (technical/nonclinical/clinical and/or procedural) section for the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
- Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for technical/nonclinical/clinical and/or procedural) and ensure that those documents meet regulatory requirements.
- For cross-product sections or stand-alone documents, work with the function to ensure content is aligned with targeted overall profile of the product.
- Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for technical/nonclinical/clinical and procedural aspects. Accountable for one or several of the RA aspects.
- Act as the point of contact for Regulatory Agencies for asset(s); Plan and lead activities associated with FDA meetings pertaining to a project/product
- Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s).
- Assess the regulatory impact of Changes pertaining to approved commercial products
- Be aware of changes in regulatory guidelines (in US and possibly globally) and their impact on regulatory strategy for the particular asset(s).
- In collaboration with the relevant RA functions, as appropriate, may possibly escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL, within the remits of his/her responsibility
- Develop and motivate collaborators (within RA team and in multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
- Ensure planning and proper organization of activities (for one or more of RA specific activities within technical/nonclinical or procedural) in line with the overall project plan and RA milestones.
- Provide input into advertising and promotional review from a regulatory perspective.
We are looking for professionals with these required skills to achieve our goals:
- Advanced Scientific Degree (Master or equivalent)
- 5+ years significant experience in regulatory affairs, or appropriate relevant experience.
If you have the following characteristics, it would be a plus:
- Ph.D. or M.D
- Broad knowledge is required and covers scientific as well as regulatory expertise.
- Previous experience in the development of medicinal products, obtaining and maintaining licenses (preferably vaccines or biologicals) in different geographical areas is preferred.
- Operational knowledge of IND and BLA regulations and experience in US regulations pertinent to CMC product development, preferably vaccines/biological
- Experience in liaison with major regulatory Agencies, preferably FDA
- Experience in providing strategic advice on integrated regulatory development plans, and problem solving in cross-functional teams in drug/vaccine development
- Ability to operate in matrix teams, working across boundaries
- Demonstrated ability to work across cultures in a global environment to meet project goals
- Evidence of proactive leadership to identify issues and propose mitigation, resolve problems through resourceful use of information and contacts, and maximize opportunities
- Fluent in English, with excellent writing skills.
- Recognized excellent communication skills, both oral and written.
- Success at managing and influencing team members without direct managerial oversight
- Self-motivated with the ability to work independently, to develop credibility with colleagues within and outside GSK
- Strategic thinker
- Enterprise thinking
- Quality mindset
Please use the cover letter to highlight how you meet the competencies for the role. Your cover letter along with your CV will be used to assess your application. Thanks for your interest in this opportunity.
Why GSK? Our values and expectationsare 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.
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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