Senior Manager, Regulatory Affairs
- Rockville, MD
Site Name: USA - Maryland - Rockville
Posted Date: Oct 19 2020
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) to drive / manage regulatory activities for a project / project within the vaccines team in order to obtain Marketing Authorisation(s) as rapidly as possible, with the best possible label, and to maintain these authorisations.
- Provide input into the content or lead preparation/authoring of relevant technical / CMC project/product specific documents submitted to regulatory agencies worldwide (e.g., MAA/BLA, variations/sBLA, Q&A, scientific consultations, Prior Approval Supplements, etc.) and ensure that these documents meet high scientific standards, regulatory requirements, and project goals.
- Ensure the tracking, delivery and approval of submissions to regulatory agencies worldwide required to establish and maintain Marketing Authorizations, ensuring routine submissions (Annual Reports) and commitments are delivered on time, and strategic submissions are completed in line with project plans.
- Support the Global Regulatory Lead in providing robust regulatory advice and submission plans to the various project teams and advisory bodies to ensure that the project plan is in compliance with global guidance documents, local regulations, and/or regulatory advice received from the agencies.
The role includes the following responsibilities:
- Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product, working with internal stakeholders and project, platform, and functional teams to provide support for technical/CMC and procedural aspects of a given project, ensuring alignment.
- Participate in complex project/product-related technical discussions and provide in-depth strategic, scientific and RA input for technical/CMC and procedural aspects of a given project within GRA meetings.
- Participate in platform, project/product, and/or region related discussions as a subject-matter expert regarding technical / CMC and procedural aspects of the project.
- Facilitate and deliver the regulatory strategy to support technical/CMC and procedural aspects of the product lifecycle, ensuring regulatory commitments and routine submissions are tracked and delivered on time.
- Provide input into or lead preparation/authoring of technical / CMC strategy documents (including Key Message Summaries) and/or submissions in collaboration with responsible functional areas, ensuring deliverables are tracked, reviewed, and approved in line with GSK procedures.
- Compile/write high quality project/product specific submissions, in line with the regulatory strategy to obtain and maintain regulatory approval world-wide, ensuring that those documents meet regulatory requirements (procedural and technical) in each region, and are aligned with global strategy.
- Provide input to Vaccines Development Plans in order to optimise the label and secure proper alignment of technical / CMC strategy and use of appropriate regulatory procedures to secure the optimum timelines.
- In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL, within the remits of his/her responsibility
- Awareness of global regulatory guidelines and their impact on regulatory strategy for the particular asset(s), including those for biologics supply.
- Develop and motivate collaborators (within RA team) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Advanced Scientific Degree
- Specialist, Global Regulatory Affairs: 4+ years significant experience in regulatory affairs, or appropriate relevant experience.
- Broad knowledge is required and covers scientific as well as regulatory expertise.
- Previous experience in the development of biological products, preferably vaccines, and obtaining and maintaining licenses in different geographical areas is preferred.
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- PhD or PharmD
- Ability to coordinate and execute regulatory strategy for a given project/product (as development path)
- Strategic thinker - ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy (as development path)
- Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximise opportunities, with proven ability to develop collaborative relationships and have high impact and influence (as development path)
- Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams (as development path)
- Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate.
- Good influencing skills.
- Culturally aware.
- Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
- Experience in the use of document management systems and project tracking (i.e., Regulatory Information Management systems) required.
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.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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