GlaxoSmithKline
Senior Manager, GRA, CMC Vx Mature Products
GlaxoSmithKline, Rockville, Maryland, us, 20849
Senior Manager, CMC Vaccines Mature Products (Global Regulatory Affairs)
Job purposeLead CMC regulatory activities in the late development and/or lifecycle management of GSK products.In this role you will…Drive the CMC strategy, coordinate the timely preparation and authors, as needed, technical (CMC) regulatory documents to support lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, taking into account the evolving regulatory requirements. Identify risks to the business associated with submission data and information packages and provide and communicate well-defined risk mitigation strategies. Play a key role in major post-approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).
Mentor or train staff. You may have direct line management responsibility and typically have significant line management experience. Manage project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate. Provide strategic direction, data assessment, and conclusions within and across departments. Establish organizational networks (internal and external) understanding departmental constraints/pressure within a highly complex organization.
Engage and may lead CMC Subject Matter Expert activities and typically have deep/specialized area of expertise, both internally (for increased compliance, harmonization and efficiency) and externally (external advocacy and shaping the regulatory environment).
May deliver CMC regulatory strategy to support major inspections (e.g., PAIs) or quality incidents (PIRCs).
Have accountability for submission content. Understand, interpret and advise on regulations, guidelines, procedures, and policies relating to development, registration, and manufacturing of biopharmaceutical products, to expedite submission, review, and approval of global CMC applications.
Ensure all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensure information submitted for lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
Formulate novel approaches and influence people, evaluating/improving CMC Regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work. Play a key role in major post-approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).
Direct and communicate complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company. Have significant experience managing agency interactions and be comfortable taking opposing views/positions assertively.
Operate with considerable independence, except for matters that affect corporate or agency policies. Rapidly and appropriately communicate sensitive matters or those with potential for high business impact.
May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
Why you?Qualifications & Skills:Master or PhD in Life sciences or related scientific discipline.
Detailed knowledge of drug development and manufacturing and supply processes.
Identified as CMC Regulatory expert in a specific subject area.
Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
Proven project management and multi-tasking skills.
Significant track record managing and directing multiple projects/teams.
Ability to play a key role in major post-approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).
Fluency in English and French.
Preferred Qualifications & Skills:Proven project management and multi-tasking skills.
Ability to manage and direct multiple projects/teams.
Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and internal colleagues in a variety of settings.
Demonstrated ability to handle complex global CMC issues through continuous change and improvement.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.Why GSK?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 organization 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.
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Job purposeLead CMC regulatory activities in the late development and/or lifecycle management of GSK products.In this role you will…Drive the CMC strategy, coordinate the timely preparation and authors, as needed, technical (CMC) regulatory documents to support lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, taking into account the evolving regulatory requirements. Identify risks to the business associated with submission data and information packages and provide and communicate well-defined risk mitigation strategies. Play a key role in major post-approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).
Mentor or train staff. You may have direct line management responsibility and typically have significant line management experience. Manage project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate. Provide strategic direction, data assessment, and conclusions within and across departments. Establish organizational networks (internal and external) understanding departmental constraints/pressure within a highly complex organization.
Engage and may lead CMC Subject Matter Expert activities and typically have deep/specialized area of expertise, both internally (for increased compliance, harmonization and efficiency) and externally (external advocacy and shaping the regulatory environment).
May deliver CMC regulatory strategy to support major inspections (e.g., PAIs) or quality incidents (PIRCs).
Have accountability for submission content. Understand, interpret and advise on regulations, guidelines, procedures, and policies relating to development, registration, and manufacturing of biopharmaceutical products, to expedite submission, review, and approval of global CMC applications.
Ensure all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensure information submitted for lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
Formulate novel approaches and influence people, evaluating/improving CMC Regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work. Play a key role in major post-approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).
Direct and communicate complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company. Have significant experience managing agency interactions and be comfortable taking opposing views/positions assertively.
Operate with considerable independence, except for matters that affect corporate or agency policies. Rapidly and appropriately communicate sensitive matters or those with potential for high business impact.
May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
Why you?Qualifications & Skills:Master or PhD in Life sciences or related scientific discipline.
Detailed knowledge of drug development and manufacturing and supply processes.
Identified as CMC Regulatory expert in a specific subject area.
Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
Proven project management and multi-tasking skills.
Significant track record managing and directing multiple projects/teams.
Ability to play a key role in major post-approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).
Fluency in English and French.
Preferred Qualifications & Skills:Proven project management and multi-tasking skills.
Ability to manage and direct multiple projects/teams.
Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and internal colleagues in a variety of settings.
Demonstrated ability to handle complex global CMC issues through continuous change and improvement.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.Why GSK?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 organization 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.
#J-18808-Ljbffr