Regulatory Affairs Manager
GSK
Are you looking for an opportunity to support a regulatory environment where you will be a part of cost reduction initiatives and ensure submission of packages are generated and provided to markets? If so, this is the role for you.
As Regulatory Affairs Management Professional you will be responsible for the execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for new product regulations and life-cycle maintenance.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Responsible for chemistry, manufacturing and controls of regulatory matters relating to registrations and/or maintenance of business activities
Prepare sections of registration files, briefing books, clinical trials applications, chemistry, manufacturing and controls variations, renewals files, and responses to Regulatory Agency questions,
Interact with colleagues in other global functions and Regulatory Affairs to deliver high quality dossiers, documents and materials to local Regulatory Affairs in accordance with business priorities
Ensure close partnership with authors, assuring technical congruency and regulatory compliance
Apply system and procedure updates to maintain proper records and support adequate controls
Provide evaluations for potential changes as requested and follow up to ensure regulatory compliance and completion of appropriate internal compliance records
Effectively communicate regulatory requirements and guidelines, facilitating timely and complete submissions
Develop up-to-date knowledge to guidelines and regulatory requirements, as well as technical trends
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience (consult manager on equivalent regulatory experience)
5+ years’ experience in regulatory affairs including chemistry, manufacturing and controls, and over the counter experience
Excellent communication, strategic thinking, and decision-making skills.
5 years of working experience in a specialized field (e.g., oncology, biologics).
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Knowledge of regulatory submissions to markets
Ability to ensure compliance standards and key performance indicators are met
Regulatory expertise in knowledge of the regulatory life cycle
Ability to interact at many levels
Technical knowledge
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.
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