- Drive the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development / registration / lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements. Identify risks to the business associated with submission data and information packages. Provide and communicate well defined risk mitigation strategies.
- Mentor or train staff. May have direct line management responsibility. 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. Able to establish organizational networks (internal and external understanding departmental constraints/pressure within a highly complex organization).
- Engage and may lead CMC Subject Matter Expert activities, 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. PAI's) 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 clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensure information submitted in clinical/marketing applications/lifecycle maintenance submissions meets regional requirements, allowing maximum Supply / Production / Quality flexibility with minimal unanticipated questions.
- Formulate novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work.
- Direct and communicate complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs ensuring optimum position for the company.
- 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.
- Master or PhD in Life sciences or related scientific discipline
- Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.
- Working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
- Developing experience in major filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development.)
- Fluency in English
- 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 personnel in a variety of settings
- Demonstrated ability to handle complex global CMC issues through continuous change and improvement.
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Director Vaccines Development CMC
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Senior Manager, Vaccines Development CMC - Waltham, United States - GlaxoSmithKline
Description
Ready to help shape the future of healthcare? Your talent can bring our science to lifeAs a , we empower you to be yourself, share ideas and work collaboratively
Senior Manager Vaccines Development CMC
Job purpose:
As a Senior Manager Vaccines Development CMC, you will lead CMC regulatory activities for investigational, late development and/or early commercial GSK products.
Please note that we currently have 4 openings as Senior Managers Vaccines Development CMC.
In this role you will...
Why you?
Qualifications & Skills:
Preferred Qualifications & Skills:
#LI-Hybrid
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?
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.
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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.
