Reg Associate Manager I

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
This is an exciting opportunity to play a key role in supporting regulatory activities for new product registrations and lifecycle management. You will collaborate with global and local teams to ensure timely and compliant submissions that align with regulatory requirements. We are looking for a detail-oriented and proactive individual who is passionate about making a meaningful impact on global healthcare. Join us to grow your career while contributing to GSK's mission of uniting science, technology, and talent to get ahead of disease together.

Basic Qualification

• Independently and confidently executes agreed dossier strategy.

• Independently manages multiple Rx and/or Vx project assignments simultaneously; assignments will range in complexity, but more complex work is expected.

• Independently completes data assessment to ensure dossier is fit for purpose.

• Identifies risks associated with submission data and information packages.

• Escalates issues with line manager that have business impact.

• May act as reviewer/approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes, policies and systems.

• Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff. 

• Understands internal/external Regulatory environment.

• Actively builds an organisational network (PSC, LOC, PO and other relevant stakeholders), promotes and is engaged in knowledge and experience sharing.

• Communicates across GSK, as necessary regarding project and policy issues ensuring optimum position for GSK.

Preferred Qualification
If you have the following characteristics, it would be a plus:

• Master's degree in a relevant field.

• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.

• Global Regulatory submission experience - Knowledge of regulatory agency guidelines

• Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines

• Excellent written and verbal communication skills and ability to present information in a clear and concise manner

• Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience

• Ability to build effective working relationships and work in a matrix environment effectively

• Ability to think flexibly in order to meet constantly shifting priorities and timelines

Work Arrangement
This role is based in India and follows a hybrid working model, combining remote and on-site work.

We are looking for individuals who are passionate about making a difference and thrive in a collaborative, fast-paced environment. If this sounds like you, we encourage you to apply

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment- to discuss your needs.

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