Senior Regulatory Specialist , New Registration CMC, CMC Excellence

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

•  Responsible for the timely delivery of regulatory activities of multiple projects across dosage forms.

•   Represents New Registration CMC, on Regulatory Networks and Matrix Teams providing guidance to Global Supply Chain (GSC), Commercial, Quality Assurance, 3rd Party Contract Management (via ESQ) and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers.

•   Will serve as a mentor/trainer for new team members.

•   May act as a Subject Matter Expert for specific areas for consultation within the team/ department as well as externally outside the department.

 

 

Responsibilities

Independently and confidently executes agreed dossier strategy. Independently manages multiple project 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. Serves as dossier reviewer for 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 (GSC, LOC, PO, team members 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.

 

Basic Qualification

Bachelor’s degree in Chemistry, pharmacy or other related biological science or technical bachelor’s degree.

English language skills.

Knowledge of drug development and manufacturing and supply processes.

Knowledge of worldwide CMC post-approval regulatory requirements.

Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager.

Service orientation, customer-focused.

Work arrangement
This role is on-site in India. You will work closely with local and global colleagues and may join virtual cross-site meetings.

Apply
If this role excites you and you want to grow your regulatory career while making a meaningful impact, we want to hear from you. Please apply and tell us how your experience matches this role. If you need any adjustments during the recruitment process, let our recruitment team know so we can support you.

Skills

Communication, Digital Fluency, Influencing Without Authority, Learning Agility, Pharmaceutical Regulatory Compliance, Problem Solving, Regulatory Strategies

 

 

Polish Salary Range / Polski przedział wynagrodzenia: PLN 144,750 to PLN 241,250The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

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-adjustments@gsk.com to discuss your needs.

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