Project Manager, CMC Regulatory Affairs
3 weeks ago
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:
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
Basic Qualifications:
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
Preferred Qualifications:
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.
Please visit to 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.
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.
-
Project Manager, CMC Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full timeAt 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...
-
Project Manager, CMC Regulatory Affairs
2 weeks ago
Mumbai, India 1925 GlaxoSmithKline LLC Full timeAt 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...
-
Project Manager, CMC Regulatory Affairs
3 weeks ago
mumbai, India 1925 GlaxoSmithKline LLC Full timeAt 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...
-
Scientist, Regulatory Affairs-cmc
2 months ago
Mumbai, India MSD Full time**Scientist Regulatory Affairs CMC** This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance’s and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for...
-
Assoc. Dir., Regulatory Affairs Cmc
6 days ago
Mumbai, India MSD Full time**Associate Director, Regulatory Affairs CMC** The Associate Director is responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidance’s, and our company's procedures. Would also lead the preparation and submission of CMC dossiers for life-cycle changes to...
-
Mumbai, India 1925 GlaxoSmithKline LLC Full timeAs Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and...
-
mumbai, India 1925 GlaxoSmithKline LLC Full timeAs Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and...
-
Mumbai, India 1925 GlaxoSmithKline LLC Full timeAs Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and...
-
Assoc. Scientist, Regulatory Affairs-cmc
3 weeks ago
Mumbai, Maharashtra, India MSD Full timeThis Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance’s and defined regulatory strategies. He would even be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Our Regulatory...
-
Mumbai, Maharashtra, India Genpact Full timeWith a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world's biggest brands—and we have fun doing it We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We're harnessing the power of technology and humanity to create...
-
Trainee Cmc
2 weeks ago
Mumbai, Maharashtra, India MSD Full time**Trainee CMC** The Trainee - Regulatory Affairs will be a part of the GRACS team which supports regional CMC strategy, preparation of CMC documentation. Under the direction of the area supervisor, responsible for the planning, preparation, and release of regulatory submissions (IND/CTA, NDA/BLA/MAA, post-approval supplements, annual reports, etc.) and...
-
Mumbai, India Genpact Full timeWith a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re harnessing the power of technology and humanity to create...
-
mumbai, India Genpact Full timeWith a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re harnessing the power of technology and humanity to create...
-
Mumbai, India Genpact Full timeWith a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re harnessing the power of technology and humanity to create...
-
mumbai, India Genpact Full timeWith a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re harnessing the power of technology and humanity to create...
-
Senior Manager, Regulatory Affairs
1 month ago
Mumbai, Maharashtra, India MSD Full timeJob DescriptionThis role involves implementing CMC regulatory strategies for pharmaceutical products in line with global regulations and established strategies. Responsibilities include preparing and reviewing information for regulatory CMC dossiers.Our Regulatory Affairs team plays a crucial role in bringing new medical advancements by facilitating...
-
Senior Manager, Regulatory Affairs
4 weeks ago
Mumbai, Maharashtra, India MSD Full timeJob DescriptionThis role involves implementing CMC regulatory strategies for pharmaceutical products in line with global regulations and established strategies. Responsibilities include preparing and reviewing information for regulatory CMC dossiers.Our Regulatory Affairs team plays a crucial role in bringing new medical advancements by facilitating...
-
Mumbai, India Abbott Full timeAbbottis a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...
-
Mumbai, Maharashtra, India Abbott Full timeAbbottis a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...
-
Regulatory Affairs Executive
3 weeks ago
Lower Parel, Mumbai, Maharashtra, India Arch Recruiting solutions Full timeUrgent Requirement Location - Lower Parel, Mumbai Designation - Regulatory Affairs - Executive Experience - 2yrs - 6yrs Qualification - B Pharma Must have Key Skills: CTD/ ACTD/ CMC/ technical review/ Dossier/ MOH queries/ Variations/ Renewals. Other essential skills: Regulated markets Job description: Common requirements: 1) Complete understanding of...
