Regulatory Affairs Product Lifecycle Management Manager
Location
India | India
Job description
Job Description
Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of categoryleading 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 in control of. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special.
Job Purpose: The objective of the Product Lifecycle Management (PLM) team is to co-ordinate and deliver the timely preparation of global renewal applications, administrative variations and safety reporting (ie PBRERs and RMPs) for the Haleon portfolio as quickly and efficiently as possible once the required data & documents are available from relevant sources, such as R&D, sites or reference markets.
This role will partner with the business to deliver robust strategic and successful regulatory outcomes for the medicinal portfolio to enable committed business plans with the ability to make independent judgment and decisions in their area of responsibility.
Key Responsibilities: - Prepare/ensure availability of high-quality documents required to support maintenance activities of product licences are completed globally, for:
- Renewals,
- Safety Reports (ie PBRERs and RMPs),
- Licence Cancellation Requests.
- Manage the execution and delivery, with close attention to detail, of 'Right First Time' dossiers, ensuring filings for planned initiatives are completed as planned and in accordance with market data requirements.
- Partner with all associated stakeholders, i.e. CMC, Category, Clinical, Medical, Safety, Local Regulatory to manage the execution and delivery of 'Right First Time' dossiers, ensuring filings for planned initiatives are completed as planned and in accordance with market data requirements.
- Support Market Specific Requirements and legal type documents which are applicable for all types of submissions. e.g. Power of Attorneys, Letters of Authorisation, Certificate of Pharmaceutical Products, Certificate of Free Sale, other supporting Regulatory Statements and arrange legalisation with Foreign Office/Embassies as required.
- Display ability to minimize impact by communicating and escalating to peers and senior management when required.
- Comply with relevant Regulatory SOPs and systems.
Knowledge - Expertise in using IT systems
- Critical assessment of processes and systems, initiates improvements as required.
General - 3ewAct as Regulatory representative on project teams, as required, understanding and applying project management tools.
- Support processes to improve ways of working /communication.
Knowledge/ Education / Previous Experience Required: Science degree/ Pharmaceutical or Life Sciences
4+ years of relevant experience
This is a role that requires a basic understanding of what Regulatory Affairs is and how this fits within the lifecycle of a product.
Diversity, Equity and Inclusion 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. Care to join us. Find out what life at Haleon is really like
Care to join us. Find out what life at Haleon is really like
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.
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