- Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
- Responsible for CMC strategy development, with managerial support, for CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and early lifecycle management activities in accordance with the applicable regulatory & scientific standards
- Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products, to expedite the submission, review and approval of global CMC applications.
- Ensures 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. Ensures information submitted in clinical/marketing applications meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
- Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
- Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
- Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
- Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency)
- Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support
- BS in a Life Sciences or related field.
- Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
- Two or more years of experience in drug development, manufacturing processes and supply chain and may have a specialized area of expertise
- MS in a Life Sciences or related field.
- RAPS Certification
- Biologics experience
- Veeva Vault experience
- Pre-approval experience (phase 1 to phase 3 submission experience)
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
-
Regulatory Affairs
1 week ago
Third Rock Ventures Waltham, United StatesThe position will provide regulatory expertise and leadership to assure that the company meets its business objectives while complying with the regulatory framework by taking into account applicable laws, regulations and guidance documents. The incumbent will be responsible for i ...
-
Regulatory Affairs
2 weeks ago
Third Rock Ventures Waltham, United StatesThe position will provide regulatory expertise and leadership to assure that the company meets its business objectives while complying with the regulatory framework by taking into account applicable laws, regulations and guidance documents. The incumbent will be responsible for i ...
-
Director, Regulatory Affairs
2 weeks ago
Dyne Therapeutics Waltham, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide th ...
-
Director, Regulatory Affairs
6 days ago
Apellis Pharmaceuticals Waltham, United StatesPosition Summary: · The Director, Regulatory Affairs will be responsible for ensuring the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategies for accountable program(s). · Key Responsibilities Include: · Ensure alignment of glo ...
-
Director, Regulatory Affairs
2 weeks ago
Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · The Director, Regulatory Affairs will be responsible for ensuring the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategies for accountable program(s). · Key Responsibilities ...
-
Manager, Regulatory Affairs
5 days ago
Deciphera Pharmaceuticals Waltham, United StatesJob Description · Job DescriptionCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhib ...
-
VP, Regulatory Affairs
4 days ago
Vigil Neuroscience, Inc. Watertown, United StatesJob Description · Job DescriptionVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. ...
-
Manager, Regulatory Affairs
2 weeks ago
Takeda Pharmaceutical Company Ltd Lexington, MA, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
-
Regulatory Affairs Specialist
3 weeks ago
Philips Cambridge, United States Full timeJOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...
-
Manager, Regulatory Affairs
3 weeks ago
Viridian Therapeutics Waltham, United StatesAt Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data- driven ...
-
Director, Regulatory Affairs
4 weeks ago
Dyne Therapeutics Waltham, United States Full timeCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide the ...
-
Director, Regulatory Affairs
1 week ago
Biofourmis Needham Heights, United StatesThe Director of Quality and Regulatory Affairs is responsible for developing and implementing the long range regulatory and compliance strategy by leading and directing the organizational development, processes and activities required to support the Biofourmis remote patient moni ...
-
Regulatory Affairs Specialist
1 week ago
Katalyst Healthcares and Life Sciences Hanscom Air Force Base, United StatesResponsibilities: Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued regulatory support of marketed devices. · Reviews and summ ...
-
VP Regulatory Affairs
1 day ago
Korro Bio, Inc. Cambridge, United StatesKorro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body's n ...
-
AD/Director, Regulatory Affairs CMC
5 days ago
Zenasbio Waltham, United StatesPosition Summary : · The AD/Director, Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) will be responsible to ensure that Zenas is executing global regulatory CMC strategies to support clinical development and commercialization readiness of biologic drug products a ...
-
AD/Director, Regulatory Affairs CMC
1 week ago
Zenas BioPharma Waltham, United StatesZenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global ...
-
Director, Regulatory Affairs
1 week ago
Relay Therapeutics Cambridge, United StatesThe Opportunity: · We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. Yo ...
-
Regulatory Affairs Manager
2 weeks ago
Katalyst HealthCares & Life Sciences Cambridge, United StatesResponsibilities: · However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs · This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requiremen ...
-
VP Regulatory Affairs
2 weeks ago
Korro Bio, Inc. Cambridge, United StatesKorro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body's n ...
-
Senior Director Regulatory Affairs
2 weeks ago
FRESENIUS MEDICAL CENTER Watertown, United StatesPOSITION FEATURES: · This is a remote position with 25% travel · PURPOSE AND SCOPE: · Manages a field team of regulatory compliance employees and provides regulatory expertise through leadership, collaboration, development, management, monitoring, analyzing, and evaluating the im ...
Project Manager, CMC Regulatory Affairs - Waltham, United States - GlaxoSmithKline
Description
Site Name: USA - Pennsylvania - Upper Providence, GSK House, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Massachusetts - Waltham, Zug HousePosted Date: May
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
Key Responsibilities:
Basic Qualifications:
Preferred Qualifications:
Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or 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.
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.
