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Head, Regulatory Affairs - Small Molecules CMC
Location:
Collegeville, PA
Description:
Job Purpose:Accountable for CMC (Chemistry, Manufacturing and Controls) Regulatory strategy and delivery for GSK's Small Molecule development portfolio, from first time in human through to Early Lifecycle and transition of CMC Regulatory accountability to the Mature Products CMC Regulatory department. Lead the department accountable for delivering CMC strategy and advice for GSK's Small Molecule development products, ensures timely advice and strategy to project teams to secure regulatory approvals for clinical trials and marketing applications globally. Key Responsibilities Establishes and directs appropriate agency communications including End of Phase 2, Pre NDA, Scientific advice, and ad-hoc product specific agency dialogue. Ensures risk assessments are conducted and appropriate mitigation and treatment plans are defined for product developments, effectively liaising with business partners and customers across Product Development, Commercial Supply Chain, GRA and product development teams. Provides appropriate GSK representation and input to product specific inspections for CMC aspects to secure approvals of new products and ensure GSK learning and continuous improvement. Directs global teams which provide the primary interface with the CMC Development and commercial supply organisations for GSK global development products including in licensed assets. Responsible for managing direct agency interface for CMC product specific aspects for all GSK development and in-licensed assets and for ensure effective negotiation of CMC agreements on behalf of R&D CMC Development and the Commercial Supply Chain. Proactively manage budget and resource requirements for the department. Liaises with the heads of CMC Regulatory Development Projects for Biopharm and Vaccines to drive aligned approaches for developments and filings, and with the CMC RA mature Products organisation to ensure an integrated regulatory strategy for products as they move towards commercial supply. Accountable for the conduct and output of the CMC RA Project Regulatory Strategy Review Forum, ensuring department embraces and drives change in regulatory approaches, seeking new and effective approaches which are aligned with emerging technology, regulatory expectations and applicable laws and regulations. Manages, coaches, and mentors staff across CMC RA Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree. Pharmaceutical industry experience with drug development and regulatory requirements in Small Molecule d Significant line leadership experience. Experience in successful CMC Regulatory filings in pharmaceutical organizations. Preferred Qualifications:If you have the following characteristics, it would be a plus: MS, PharmD, PhD. The ability to influence effectively in a matrix. Highly developed interpersonal, presentation and communication skills with established internal and external networks. Excellent understanding and extensive experience of product development and technical regulatory requirements. Extensive expertise of diverse market environments and requirements. Proven ability to assimilate new and emerging requirements and establish optimized approach in global context. Extensive development experience including previous roles within product development, deep expertise and understanding of regulatory agencies worldwide and proven ability to effectively interface and communicate with global regulatory agencies. 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, it's 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.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on XXXX@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receiveAs you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. 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.PDN-9c7c74fb-8851-4398-84a3-fd43d3e97da8
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Head, Regulatory Affairs - Small Molecules CMC is a Other Jobs Head Regulatory Affairs Job at GSK located in Collegeville PA. Find other listings like Head, Regulatory Affairs - Small Molecules CMC by searching Oodle for Other Jobs Head Regulatory Affairs Jobs.
Head, Regulatory Affairs - Small Molecules CMC is a Other Jobs Head Regulatory Affairs Job at GSK located in Collegeville PA. Find other listings like Head, Regulatory Affairs - Small Molecules CMC by searching Oodle for Other Jobs Head Regulatory Affairs Jobs.