Regulatory Manager, Product Lifecycle Management, Open to flexible working
Here at GSK, we are looking for a Regulatory Manager to join our dynamic, high performing team.
As Regulatory Manager - Product Lifecycle Management, you will be accountable for co-ordinating and delivering the timely preparation of global renewal applications, administrative variations and safety reporting (ie.PBRERs) for the GSK Consumer 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 reports to the Senior Manager Regulatory Affairs (non medicinals), Product Lifecycle Management.
Furthermore, you will assume responsibility for several products with various legal status' including cosmetics, medicinal and medical devices. This position requires an understanding of the differences between the regulations and associated requirements for these different product types.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities involve the following:
- Comprehensive understanding of Global Regulatory requirements, specifically for maintenance activities such as renewal application and post-launch variations, so to efficiently plan and communicate these requirements to stakeholders (CDMA, CMC etc) to ensure timely & complete delivery of these documents.
- Agree & communicate plans required for Regulatory submissions in markets to meet renewal, admin variation and safety reporting timings, expectations and milestones.
- Proactively seek updates and changes in Regulatory Intelligence for market requirements and communicate these to relevant stakeholders.
- Partner with Central Regulatory colleagues (ie CMC), CDMA, Manufacturing and LOCs to ensure clear communication and understanding of priorities, planned activities (i.e. renewals) and process requirements.
- Contributes as Regulatory representative into priority project initiatives on behalf of GSK Consumer Healthcare. Ensure adequate Regulatory support is provided to deliver project objectives.
- Manage the execution and delivery of 'Right First Time' dossiers, ensuring filings for planned initiatives are completed as planned.
- Prepare/ensure availability of high quality documents required to support renewal, admin variations and safety reporting applications and ensure maintenance and lifecycle management in accordance with market data requirements.
- Display ability to resolve unexpected issues/challenges and minimise impact by communicating and escalating to peers and senior management when required
- Expertise in using required IT Regulatory systems, including Documentum.
- Critical assessment of processes and systems, initiates improvements as required.
- Act as Regulatory expert in project teams, working with cross-functional teams and Category colleagues to provide strategy and solutions to overcome issues and challenges.
- Take ownership of Regulatory-specific processes; establish improved ways of working /communication within Central Regulatory, LOCs and manufacturing sites.
You will have an established understanding of the Regulatory Affairs role, with previous experience in a similar Regulatory Affairs role.
- Degree level education in Pharmaceutical or Life Sciences
- Extensive experience in a related Regulatory Affairs role which would have covered the following:
- Direct experience with medicinal product regulations
- Direct experience with cosmetic product regulations
- Experience with medical device regulations
- Proven record of developing and leading regulatory strategies for complex situations
- Experience of working flexibly across a portfolio of products
- Awareness of regulatory processes in different geographic regions, e.g. Emerging markets, Japan.
- Knowledge of eCTD and related electronic submission processes.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
GlaxoSmithKline is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. We discover, make and market life-enhancing products that are used by millions of people around the world, helping them to do more, feel better and live longer. We have 3 primary areas of business in pharmaceuticals, vaccines and consumer healthcare. We have offices in more than 115 countries, major research centers in the UK, USA, Spain, Belgium and China and an extensive manufacturing network with 87 sites globally. Our three strategic priorities are to grow a diversified global business, deliver products of value, and to simplify our operating model.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
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.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.
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