Job Information
Haleon US Regulatory Lead – Rx to OTC Switch in Warren, New Jersey
Are you looking for a regulatory affairs leadership role where you can shape and accelerate regulatory effectiveness across the organization? If so, this Regulatory Affairs Operations Director role could be an exciting opportunity to explore.
As a Regulatory Affairs Operations Director, you will be responsible for enforcing global standards and policies, interfacing with internal and external decision-making bodies, and creating a framework of effective and compliant regulatory processes, documentation, and systems.
This role will provide/gives YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Develop and provide strategic direction for regulatory governance, compliance, systems, and business performance.
Advise Regulatory and senior management on issues relating to regulatory policies and product labelling.
Interface with senior leaders the businesses to develop, implement, and maintain policies and standards.
Engage with Regulatory Authorities in area impacting regulatory policy and labelling standards and polices directly or collectively through professional organizations / associations.
Analyze changes to key Regulatory Authorities’ policies relating to drug labelling and recommend/coordinate modifications of current practices, as appropriate.
Act as primary Global Regulatory representative, including the Global Regulatory Committee and Regulatory Safety Committee, engaging other staff as appropriate.
Be responsible for business representation for all internal and external regulatory inspections or audits that involve Labelling processes and/or personnel.
Define compliance and performance metrics to ensure Global Labelling is meeting and exceeding standards.
Line manage staff engaged in governance, compliance, systems, and business performance.
Act as approver for documentation and systems that impact compliance with relevant regulatory requirements or regulations.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree.
Pharmaceutical industry experience with drug development and regulatory requirements.
Line leadership experience.
Experience with scientific data interpretation and labelling content.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
MS, PharmD, PhD.
The ability to influence effectively in a matrix.
Experience with OTC and Consumer Healthcare.
Highly developed interpersonal, presentation and communication skills with established internal and external networks.
Why Haleon?
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:
Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
Managing individual performance.
Creating a performance culture and driving results, prioritisation, execution, delivering performance.
Setting strategic direction and leading on-going organisational transformation.
Building a resilient organisation.
Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
Managing P&L and capital allocation.
Salary range: $247,605 - $309,507
This positing will close on December 2nd
*This is a job description to aide in the job posting but does not include all job evaluation details.
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 and, in the US, we adhere to Affirmative Action principles. This ensures that 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.
Hello. We’re Haleon. A new world-leading consumer healthcare company. Shaped by all of us. Together, we’re improving everyday health for millions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re building together. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.