Regulatory Associate Manager- CMC variations, Small molecules

Business Introduction
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. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D

Position Summary
In this role, you will lead regulatory activities for product variations, ensuring compliance and quality across multiple projects. You will work closely with cross-functional teams, including supply chain, quality assurance, and commercial teams, to support global regulatory submissions. We value individuals who are detail-oriented, proactive, and committed to delivering high-quality results. This is an opportunity to make a meaningful impact while advancing your career in a collaborative and inclusive environment.

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Manage regulatory activities for product variations across multiple projects, ensuring timely delivery and compliance.
- Collaborate with internal and external stakeholders to produce high-quality components for global regulatory dossiers.
- Assess data to ensure submissions are fit for purpose and identify risks associated with submission packages.
- Act as a reviewer or approver for regulatory dossiers prepared by peers, driving process improvements.
- Provide guidance on regulatory requirements, policies, and procedures to expedite submission and approval processes.
- Build effective networks within the organization to share knowledge and promote best practices.

Basic Qualification

• Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Pharma products (working with the CTD Module 3, Quality section of the dossiers).

• Managing assigned projects by executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and in compliance with GSK regulatory processes and external requirements for local markets (e.g., Europe, US, and International countries), and identifying risks associated with submission data and information packages.

• Preparing and coordinating the review and approval of submission-ready documents.

• Collaborating with Product Owners/Project Managers to provide regulatory support for assigned projects.

• Working with colleagues in the Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies in markets worldwide to deliver high-quality dossiers on time.

• Building and maintaining strong relationships with internal and external stakeholders.

• Monitoring regulatory intelligence and proactively acting on identified changes to regulatory requirements.

• Identifying improvement opportunities for CMC regulatory processes, policies, and systems.

Preferred Qualification

• Bachelor's or Master's degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.

• Relevant experience  in regulatory affairs (the pharmaceutical industry), with familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).

• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.

• Thorough understanding of change management processes and regulatory requirements.

• Attention to detail with an emphasis on accuracy and completeness.

• Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs.

• Flexible and analytical thinking to independently provide solutions to issues.

• Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.

• Excellent written and verbal communication skills in English.

This role is based in India and will require on-site work with opportunities for collaboration across global teams. If you're ready to take the next step in your career and contribute to a mission-driven organization, we encourage you to apply today

Business Introduction
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. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D

Position Summary
In this role, you will lead regulatory activities for product variations, ensuring compliance and quality across multiple projects. You will work closely with cross-functional teams, including supply chain, quality assurance, and commercial teams, to support global regulatory submissions. We value individuals who are detail-oriented, proactive, and committed to delivering high-quality results. This is an opportunity to make a meaningful impact while advancing your career in a collaborative and inclusive environment.

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Manage regulatory activities for product variations across multiple projects, ensuring timely delivery and compliance.
- Collaborate with internal and external stakeholders to produce high-quality components for global regulatory dossiers.
- Assess data to ensure submissions are fit for purpose and identify risks associated with submission packages.
- Act as a reviewer or approver for regulatory dossiers prepared by peers, driving process improvements.
- Provide guidance on regulatory requirements, policies, and procedures to expedite submission and approval processes.
- Build effective networks within the organization to share knowledge and promote best practices.

Basic Qualification

• Managing multiple project assignments simultaneously, including CMC variations, source transfers, and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Pharma products (working with the CTD Module 3, Quality section of the dossiers).

• Managing assigned projects by executing agreed dossier strategies, completing data assessments to ensure dossiers are fit for purpose and in compliance with GSK regulatory processes and external requirements for local markets (e.g., Europe, US, and International countries), and identifying risks associated with submission data and information packages.

• Preparing and coordinating the review and approval of submission-ready documents.

• Collaborating with Product Owners/Project Managers to provide regulatory support for assigned projects.

• Working with colleagues in the Global Supply Chain, Global Regulatory Groups, and GSK Local Operating Companies in markets worldwide to deliver high-quality dossiers on time.

• Building and maintaining strong relationships with internal and external stakeholders.

• Monitoring regulatory intelligence and proactively acting on identified changes to regulatory requirements.

• Identifying improvement opportunities for CMC regulatory processes, policies, and systems.

Preferred Qualification

• Bachelor's or Master's degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.

• Relevant experience  in regulatory affairs (the pharmaceutical industry), with familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).

• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.

• Thorough understanding of change management processes and regulatory requirements.

• Attention to detail with an emphasis on accuracy and completeness.

• Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs.

• Flexible and analytical thinking to independently provide solutions to issues.

• Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.

• Excellent written and verbal communication skills in English.

This role is based in India and will require on-site work with opportunities for collaboration across global teams. If you're ready to take the next step in your career and contribute to a mission-driven organization, we encourage you to apply today

Dlaczego GSK?

Łączymy naukę, technologię i umiejętności, aby razem pokonywać choroby.

GSK to globalna firma biofarmaceutyczna, której celem jest łączenie nauki, technologii i talentów, aby wspólnie wyprzedzać choroby. Jako odnosząca sukcesy, rozwijająca się firma, w której ludzie mogą realizować swój potencjał, dążymy do pozytywnego wpływu na zdrowie 2,5 miliarda ludzi do końca dekady.

Priorytetem są dla nas innowacyjne rozwiązania w obszarze szczepionek i leków specjalistycznych, które maksymalizują rosnące możliwości w zakresie zapobiegania chorobom i ich leczenia.

Skupiamy się na czterech obszarach terapeutycznych: układzie oddechowym, immunologii; onkologii; HIV; oraz chorobach zakaźnych – aby wpływać na zdrowie na dużą skalę.

Ludzie i pacjenci na całym świecie polegają na lekach i szczepionkach, które produkujemy, dlatego zobowiązujemy się do tworzenia środowiska, w którym nasi pracownicy mogą się rozwijać i koncentrować na tym, co najważniejsze. Nasza kultura bycia ambitnym dla pacjentów, odpowiedzialnym za wpływ i postępowania właściwie jest fundamentem, na którym wspólnie dostarczamy rezultaty dla pacjentów, akcjonariuszy i naszych pracowników.

Inkluzywność w GSK:

Jako pracodawca zaangażowany w kwestie inkluzywności, zachęcamy do kontaktu, jeśli potrzebujesz jakichkolwiek zmian w trakcie procesu rekrutacji.

Skontaktuj się z naszym zespołem ds. rekrutacji pod adresem IN.recruitment-, aby omówić swoje potrzeby.

Ważna informacja dla firm/agencji zatrudnienia

GSK nie przyjmuje poleceń od firm/agencji rekrutacyjnych lub pośrednictwa pracy w odniesieniu do wakatów zamieszczonych na tej stronie. Wszystkie firmy/agencje są zobowiązane do skontaktowania się z Działem Zakupów Usług Komercyjnych/Działem HR GSK w celu uzyskania uprzedniej pisemnej zgody przed skierowaniem jakichkolwiek kandydatów do GSK. Uzyskanie uprzedniej pisemnej zgody jest warunkiem wstępnym każdej umowy (ustnej lub pisemnej) między firmą/agencją a GSK. W przypadku braku takiego pisemnego upoważnienia wszelkie działania podejmowane przez firmę/agencję będą uznawane za wykonane bez zgody lub umowy kontraktowej GSK. GSK nie ponosi zatem odpowiedzialności za żadne opłaty wynikające z takich działań lub opłaty wynikające z jakichkolwiek poleceń firm/agencji w odniesieniu do wakatów zamieszczonych na tej stronie.

Dotarła do nas informacja, że nazwy GlaxoSmithKline lub GSK lub spółek naszej grupy są wykorzystywane w związku z fałszywymi ogłoszeniami o pracę lub za pośrednictwem niezamawianych wiadomości e-mail, w których kandydaci są proszeni o dokonanie pewnych płatności za możliwości rekrutacji i rozmowy kwalifikacyjne. Należy pamiętać, że takie reklamy i wiadomości e-mail nie są w żaden sposób powiązane z grupą GlaxoSmithKline (lub GSK).

GlaxoSmithKline (lub GSK) nie pobiera żadnych opłat za proces rekrutacji. Prosimy nie dokonywać płatności na rzecz żadnych osób/podmiotów w związku z rekrutacją w żadnej spółce grupy GlaxoSmithKline (lub GSK) w żadnej lokalizacji na świecie. Nawet jeśli twierdzą, że pieniądze podlegają zwrotowi.

Jeśli natkniesz się na niechciane wiadomości e-mail z adresów, które nie kończą się na lub na ogłoszenia o pracę, w których napisano, że należy kontaktować się z adresem e-mail, który nie kończy się na "", powinieneś je zignorować i poinformować nas, wysyłając wiadomość e-mail na adres , abyśmy mogli potwierdzić, czy oferta pracy jest prawdziwa.