RA Manager

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)
• 1+ years’ experience in regulatory affairs including chemistry, manufacturing and controls, and over the counter experience
  

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?
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness
  

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.
Important note to candidates:
The Haleon recruitment team will only contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.