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Manager, CMC

Employer
GSK
Location
Rockville, Maryland
Salary
Competitive
Closing date
Jan 28, 2022

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Sector
Pharmaceutical
Organization Type
Corporate
Jobseeker Type
Professional
Site Name: USA - Maryland - Rockville, Belgium-Wavre Posted Date: Jan 7 2022 Are you energized by a challenging role in pharmaceutical R&D, where scientific demand is driving team growth? If so, this Manager, CMC would be a great opportunity to consider. As a Manager, CMC, you will be responsible for the CMC regulatory activities of multiple projects This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Drives the CMC strategy, coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development and registration of new vaccines or lifecycle activities and maintenance of registered vaccines, in accordance with the applicable regulatory & scientific standards, taking into account the evolving regulatory requirements. Provides regulatory advice and guidance to the Technical Development Team and/or Technical Life-Cycle Team (TLCT), Implementation Committee, Specification Review Committee, Technical Review Board, CMC Expert Panel, and provides regulatory support to their partners in R&D, Quality Control, Manufacturing, QA and Supply. Ensures adequate interaction and partnership with the Global Regulatory Lead's team in order to define proper regulatory CMC filing strategy. Ensures adequate contribution during interactions with Worldwide regulatory authorities. Ensures, in a continuous improvement mindset, regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions. May engage and lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment). May mentor or train staff. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects. May deliver CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs). Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in Sciences or Medical Sciences Experience managed multiple projects simultaneously. Experience in drug development and manufacturing and supply processes and may have a specialized area of expertise. Experience in CMC regulatory requirements. Experience handling global CMC issues through continuous change and improvement Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's degree or above in Chemistry, pharmacy, biological or closely related science advanced degree. Regulatory Affairs Certification (e.g. RAPS) Experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of leadership in a matrix environment. Sound knowledge of vaccines/biological products development, manufacturing and supply processes. Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements. Identified as CMC Regulatory expert in a specific subject area. Highly developed interpersonal, presentation and communication skills. Proven experience in training staff within an organisation. Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're 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 you're 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 If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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.

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