Regulatory Project Manager New Registration CMC CMC Excellence
Regulatory Project Manager New Registration CMC CMC Excellence
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Job Description
Regulatory Project Manager New Registration CMC CMC Excellence
Within the CMC RA group the New Registrations CMC team bring together the operation and aspects for key regulatory deliverables such as new chemical entity product expansion dossiers and CTA submissions. The New Registrations CMC team provide regulatory support across for development and registration of new pharmaceutical biopharm and vaccines products.
This role will provide YOU the opportunity to lead key activities to progress YOUR career these responsibilities include some of the following
- Independently assesses manages and/or drives the CMC strategy coordinates timely prepares and authors multiple complex CMC technical regulatory documents to support applications forclinical trialsmarketing authorisation lifecycle activities and maintenance of registered products across Rx Bx and Vx portfolios in accordance with the applicable regulatory and scientific standards taking into account the evolving regulatory requirements
- Understands internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to inlicensing and divestment projects and provide guidance to R&D teams Quality Control GSC QA and LOC
- Ensures adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus
- Ensures adequate contribution during interactions with Worldwide Regulatory Authorities.Authors responses to Regulatory Agency questions
- Understands regulations guidelines procedures and policies relating to registration and manufacturing of pharmaceutical products to expedite submission review and approval of global applications while ensuring regulatory compliance is maintained and sharing bestpractices and learnings within the CMC Regulatory teams and other impacted functions.May engage and lead CMC Subject Matter Expert activities
- Identifies risks associated with submission data and information packages and can influence people systems processes and formulate alternative approaches
- Contributes to and leads (as required) the creation maintenance and continuous improvement of CMC Regulatory processes work instructions policies and systems
- Ensures information submitted in marketing applications meets CMC and regional requirements and escalates to line manager as applicable risk or issues that have business impact
- Communicates through the appropriate teams complex regulatory issues across GSK and with external agencies and third parties as necessary
- May represent GSK externally (e.g. Audits Conferences External Forums)
- Independently manages the completion of data assessment ensures all appropriate CMC regulatory aspects serves as dossier approver identifies improvement opportunities and confidently executes a dossier that is fit for purpose per agreed dossier strategy and timelines
Why you
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- PhD/Masters degree or above in Pharmacy Biotechnology Biology Chemistry or closely related science advanced degree
- Significant experience in Pharmaceutical industry or Research organizations established in Regulatory Affairs. Project Management skills
- The ability to understand the scientific content of CMC technical documentation
- Sound knowledge and understanding of drug development and manufacturing and supply processes and may have a specialized area of expertise.
- Demonstrated ability to handle complex global CMC submissions and issues through continuous change and improvement
- Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment
- Proven project management and multitasking skills. High ability to manage matrix teams and direct multiple projects
- Experience in influencing and negotiating with GSK personnel in a variety of settings
Preferred Qualifications:
If you have the following characteristics it would be a plus:
- Significant experience in Pharmaceutical industry or Research organizations established in Regulatory Affairs
- Identified as CMC Regulatory expert in a specific subject area.
- Highly developed interpersonal presentation and communication skills with established internal and external networks
- Attention to detail excellent organization time management and multitasking skills to handle multiple projects for different customers
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Service oriented and customer focused
- Clear and effective verbal and written communication skills in the English language
- Veeva Vault knowledge would be an asset
Why GSK
At GSK we offer a wide range of additional benefits:
- Career at one of the leading global healthcare companies
- Hybrid work 2/3 days per week from the office)
- Contract of employment
- Attractive reward package (annual bonus & awards for outstanding performance recognition awards for additional achievements and engagement holiday benefit)
- Life insurance and pension plan
- Private medical package with additional preventive healthcare services for employees and their eligible counterparts.
- Sports cards (Multisport)
- Possibilities of development within the role and companys structure
- Personalized learning approach (internal trainings mentoring access to online training platforms: Keep Growing Campus LinkedIn Learning Business Skills Harvard Manage Mentor Skillsoft and external training)
- Extensive support of work life balance (flexible working solutions short Fridays option health & wellbeing activities)
- Supportive community and integration events
- Modern office with creative rooms fresh fruits every day
#LIGSK
#LIHYBRID
As an Inclusive employer we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team atto discuss your needs.
Why GSK
Uniting science technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose to unite science technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger more sustainable shareholder returns as an organisation where people can thrive. We prevent and treat disease with vaccines specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas (infectious diseases HIV respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome valued and included. Where they can keep growing and look after their wellbeing. So if you share our ambition join us at this exciting moment in our journey to get Ahead Together.
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 GSKs 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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
IC
Employment Type
Full-Time
Key Skills
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