6+ years significant experience in regulatory affairs, or appropriate relevant experience.
• Requires scientific and regulatory knowledge pertinent to development aspects, particularly Clinical RA and strategy
• Operational knowledge of IND and BLA regulations and experience in US regulations pertinent to product development, preferably vaccines/biological
• Experience in liaison with major regulatory Agencies, preferably FDA
• Demonstrated knowledge in regulatory affairs and drug/vaccine development or equivalent
Ph.D; Pharmacy, Chemistry, Biology or Medicine
Pharmaceutical development with biologics experience preferred.
• Experience in providing strategic advice on integrated regulatory development plans, and problem solving in cross-functional teams in drug/vaccine development
•Ability to coordinate and execute regulatory strategy for a given project/product.
•Ability to assess and determine regulatory strategy for development and life cycle management programs.
•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 Global Regulatory Lead and to propose mitigation strategies, maximize 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 groups within GSK or to regulatory agencies, as appropriate.
•Proven 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 assess the potential impact on RA, including how RA may facilitate in achieving the overall goal.
•Fluent in English, with excellent writing skills.
•Able to input into the Company's regulatory positioning, and write /critically review key documents targeting internal or external key audiences.
•In collaboration with the function and regions, ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.
•Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.
• Interact with (or represents his/her area/product at) internal project related teams, for all parts of RA aspects of a given project on clinical RA strategy or procedural aspects.
• Participate in project/product-related discussions and provide strategic, scientific and RA input, for all parts of RA aspects of given project on clinical or procedural aspects.
• Provide input into the asset specific regulatory strategy on a global scale.
• Provide support to the GRL via authoring, input and/or critical review of one or more specific sections of regulatory documents, Global Regulatory Plan(s) and/or Key Message Summaries.
• Coordinate (for one or more specific sections) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with the GRL
• For cross-product sections or stand-alone documents work with the functional regulatory groups to ensure content is aligned with targeted overall profile of the product.
• Compile/write high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements.
• Facilitate and deliver the regulatory strategy to support the lifecycle of the asset; contribute for clinical and procedural and accountable for one or several of the RA aspects.
• Act as the point of contact for Regulatory Agencies for assets ; 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).
• 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 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 clinical or procedural) in line with the overall project plan and RA milestones.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. 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.
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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
A little about us:
We are a science-led global healthcare company on a mission to help people to do more, feel better and live longer.