Regulatory Project Manager, New Registration CMC

GSK; Bengaluru; Hybrid; INR 183,750 - 306,250; Full time

Benefits offered by this job

Medical Plan

Life Insurance

Employee Retirement Program

Recreation allowance

Annual bonus

Flexible working hours

Job summary

A leading global biopharma company is seeking a Regulatory Project Manager for New Registration CMC in Bengaluru, India. This role involves managing regulatory submissions and providing guidance on product registration while ensuring compliance with global standards. Candidates should possess experience in managing complex regulatory documents and strong stakeholder communication skills. The position offers a hybrid work model, a supportive environment, and several benefits, including medical plans and performance bonuses.

Qualifications

• Experience in managing CMC regulatory submissions.
• Ability to communicate complex regulatory issues.
• Understanding of global regulations and guidelines.

Responsibilities

• Manage CMC submission deliverables and technical regulatory documents.
• Guide regulatory strategy for new product registrations.
• Interact with Regulatory Authorities to ensure compliance.

Skills

CMC submission management

Regulatory advice

Stakeholder communication

Risk assessment

Regulatory compliance

Education

Degree in a relevant field

Pharmaceutical regulatory knowledge

Job description

Regulatory Project Manager, New Registration CMC

Join to apply for the Regulatory Project Manager, New Registration CMC role at GSK

Within the CMC RA group, the New Registration CMC team bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity, product expansion dossiers and CTA submissions. The team provides regulatory support across development and registration of new pharmaceutical, biopharm and vaccines products.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Independently assesses, manages, and/or drives the CMC submission deliverables, coordinates, timely prepares, and authors multiple complex CMC technical regulatory documents to support applications for clinical trials, marketing authorisation, lifecycle activities and maintenance of registered products across Rx, Bx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the evolving regulatory requirements
• Understands internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to in-licensing and divestment projects, and provide guidance to R&D teams, Quality Control, GSC, QA and LOC
• Ensures adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus
• Ensures adequate contribution during interactions with Worldwide Regulatory Authorities. Authors responses to Regulatory Agency questions
• Understands regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications while ensuring regulatory compliance is maintained and sharing best‑practices and learnings within the CMC Regulatory teams and other impacted functions. May engage and lead CMC Subject Matter Expert activities
• Identifies risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches
• Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems
• Ensures information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact
• Communicates, through the appropriate teams, complex regulatory issues across GSK and with external agencies and third parties as necessary
• Independently manages the completion of data assessment, ensures all appropriate CMC regulatory aspects, serves as dossier approver, identifies improvement opportunities, and confidently executes a dossier that is fit for purpose per agreed dossier strategy and timelines

What we offer

• Performance with Choice – flexibility in working mode (hybrid working model 2/3 days per week in the office), flexible working hours.
• Established job in an international, well‑known pharmaceutical company.
• Opportunity to work in professional team playing crucial role in maintaining GSK portfolio on the markets.
• Opportunity to work within GSK standards and documentation applied globally.
• Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus).
• Supportive & friendly working environment.

The annual base salary in Poland for new hires in this position ranges from PLN 183,750 to PLN 306,250 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non‑discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process…

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [e-mail] to discuss your needs.

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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.