1+ months

Senior Manager Global Regulatory Affairs

Site Name: Belgium-Wavre, Italy - Siena, Rockville Vaccines Posted Date: Jun 29 2022 As Delegate for the Global Regulatory Lead (GRL), you will have global responsibility of regulatory activities for the Infanrix/Boostrix portfolio within GSKs OneR&D department. Infanrix/Boostrix is GSKs portfolio of combination vaccines protecting against up to six diseases (diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by H. influenza type-b bacteria). You will contribute to the development and execution of regulatory strategies that will establish 1) adult and maternal Boostrix vaccination as the standard of care by offering full lifespan protection, and 2) Infanrix as the most trusted hexavalent vaccine. Your responsibilities: Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product. Participate to project/product-related discussions such as Regulatory Management Team and provides in-depth strategic, scientific and RA input, for clinical/labelling or procedural aspects of given project. Provide support to the GRL via critical review of the clinical/labelling or procedural section of regulatory documents, Global Regulatory Plans and Key Message Summaries. Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for clinical/labelling or procedural sections) and ensure that those documents meet regulatory requirements. Ensure planning and proper organisation of activities (for clinical/labelling or procedural activites) in line with the overall project plan and RA milestones Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical/labelling and/or procedural aspects May possibly act as the point of contact for Regulatory Agencies for asset(s) (project-specific), including EU agent role 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) Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s) Develop and motivate collaborators (within RA team or for one of the RA aspects with multidisciplinary teams) 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 4+ years significant experience in regulatory affairs, or appropriate relevant experience Broad knowledge is required and covers scientific as well as regulatory expertise Ability to coordinate and execute regulatory strategy for a given project/product. Strategic thinker ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy. 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 Good presentation skills to ensure that GSK Vaccines regulatory voice is clearly articulated and heard in the various cross functional teams. Support the Global Regulatory Lead to ensure regulatory input is provided to other GSK divisions or to regulatory agencies, as appropriate. Good influencing skills. Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner Ability to resolve problems through resourceful use of information and contacts. Enterprise thinking needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal. Quality mindset Fluent in English, with excellent writing skills. Preferred Qualifications: If you have the following characteristics it would be a plus: Ph.D. or M.D Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, were making the most significant changes weve made to our business in over 20 years. Were on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients so we deliver what matters better and faster; accountable for impact with clear ownership of goals and support to succeed; and where we do the right thing. So, if youre ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *Li-GSK #VaccinesRD If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements. Our goal is to be one of the worlds most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.","street_address":"Avenue Fleming 20 1300 Wavre Belgium",


Posted: 2022-06-29 Expires: 2022-08-28

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