• Scientific degree in chemistry, pharmacy or related discipline with preference for a second degree/PhD..
• Extensive experience of drug development, manufacturing with established Regulatory Affairs capability through development and early commercial supply. Proven experience and demonstrated delivery of regulatory activities for:
• All dosage forms (tablets, capsules, creams, respiratory devices, suspensions, steriles etc) and therapeutic areas GSK supports. Extensive experience is required to formulate effective regulatory approaches according to new and emerging guidance globally and regulatory experience across diverse global markets
• Interaction with regulatory agencies worldwide and proven ability to effectively interface and communicate to secure submission and approval outcomes. .
• Diverse market environments and requirements. Proven ability to assimilate new and emerging requirements and establish optimized approach in global context.
• Proven and effective line management capability
• Excellent understanding and extensive experience of product development and technical regulatory requirements.
GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical companies. Our powerful combination of skills and resources provide the platform for delivering strong growth and responding quickly to the rapidly changing global healthcare environment. We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas: Pharmaceuticals, Vaccines and Consumer Healthcare. We have a significant global presence with commercial operations in more than 150 markets, a network of 86 manufacturing sites in 36 countries, and large R&D centers in the UK, USA, Spain, Belgium and China.
R&D innovation underpins all of our businesses. We partner with more than 1,500 other companies and academic organisations around the world, enabling us to increase our understanding of new areas of science and to share the risk of development. We have a deep portfolio of innovation focused across six core areas of scientific research and development: HIV and infectious diseases, oncology, immuno-inflammation, vaccines, respiratory and diseases. Since 2013 we saw significant delivery from our late stage pipeline, with six key medicines approved by regulators in the USA alone. We are one of the few healthcare companies researching medicines and vaccines for the World Health Organization's three priority diseases - HIV/AIDS, tuberculosis and malaria. GSK employs over 12,500 individuals whom work in research to discover new medicines, screening millions of compounds every year. GSK vaccines are included in immunization campaigns in 182 countries with 860 million vaccine doses distributed to 170 countries in 2013, of which 80% were to developing countries.
CMC Global Regulatory Affairs
Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and Global Manufacturing and Supply to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and Advanced Manufacturing Technology for multiple modalities for small and large molecules through to Cell and Gene Therapy.
You will lead and direct a group/department of regulatory experts based in the UK and US accountable for delivering global regulatory CMC strategy and files for all Pharma products through clinical trials and initial marketing applications. This involves driving development decisions and programs to ensure regulatory applications are compliant and optimal regulatory approaches secured to enable clinical trials and marketing authorisation approvals worldwide. You will influence the adoption of novel manufacturing and control technologies across all dosage forms GSK develops and also join a leadership team which includes Biopharm, nonclinical and post approval CMC leaders.
You will have global accountability for Chemistry, Manufacturing and Controls (CMC) Regulatory activities for all small molecule GSK development products, including in-licensed assets from initial clinical studies through to early commercial supply. You manage the department accountable for delivering CMC strategy, advice and submission delivery for all GSK development products through clinical trials and marketing applications, ensuring timely advice and strategy to project teams so as to secure regulatory approvals globally. You will have knowledge and introduce advanced manufacturing technology concepts through seeking and defining effective regulatory approaches through close liaison with stakeholders and effective agency engagement. Finally, you will establish and direct appropriate agency communications including End of Phase 2, Pre NDA, Scientific advice and ad-hoc product specific agency dialogue.
Successful Candidate Profile
You will possess a bachelors degree along with extensive experience across all dosage forms (tablets, capsules, creams, respiratory devices, suspensions, steriles etc) and therapeutic areas in order to formulate effective regulatory approaches according to new and emerging guidance globally and regulatory experience across diverse global markets. You will have previous experience within product development, have deep expertise and understanding of regulatory agencies worldwide and proven ability to effectively interface and communicate with global regulatory agencies. You will also have previous line management experience. You are identified as a CMC Regulatory expert and you mentor your colleagues on the latest developments in this field. You possess detailed knowledge of drug development and manufacturing and supply processes. Your project management and multi-tasking skills will serve you well in this role. You will also have a history of managing complex global CMC issues through continuous change and improvement. Finally, you will have a demonstrated track record of effective influencing and negotiating with regulatory agencies, industry bodies, and in a variety of settings.
Salary & Benefits
GSK offers a comprehensive salary & benefits package to include healthcare for yourself and dependents, performance related bonus, car/transport allowances, Long Term Incentives (LTI's) as well as a host of other flexible benefits you can tailor to your own preferences. At GSK, we are proud of our collaborative and flexible working culture.
If this opportunity is in line with your profile as well as your career trajectory, we would urge you to apply. When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application
Following your application, we will advise you on the viability of your candidacy. Should you enter into the formal interview process you will have the opportunity, through interviews with a variety of key stakeholders, to develop your understanding of the role and GSK.
We hope you can understand that, if your profile is not appropriate for this particular role, we cannot guarantee we will be able to provide timely feedback on every occasion.
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.
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