الصفحة الرئيسية المملكة المتحدة Director of Regulatory CMC.
الصفحة الرئيسية المملكة المتحدة Director of Regulatory CMC.
Director of Regulatory CMC.
دوام كامل
في Mundipharma
في
United Kingdom
نُشرت يوم November 25, 2024
تفاصيل الوظيفة
ARA-M4-14
- Location: Cambridge (Home working with some travels to Cambridge when needed)
- Job type: Permanent At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. We are looking for a CMC Director to efficiently manage and deliver the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Products across EU and ROW. The person will also be responsible for building and maintaining a strong collaborative partnership with products teams especially with team members from Tech Ops and Quality. They will act as Senior Oversight for RA CMC activities and ensure effective, quality delivery of CMC support from vendors.They will also lead a team of permanent employees (CMC regulatory) and supervise contractors and consultants supporting the CMC regulatory objectives and deliverables. Key Responsibilities
- Responsible for RA CMC for products including RA CMC strategy and oversight of vendor delivery.
- Ensure that RA CMC strategies fully recognise risk, provide mitigations and ensure that these are communicated and acknowledged within the organisation for appropriate product team decision making.
- Escalation point for vendors for RA CMC strategy for products and review of delivery output from vendors to ensure that it is fit for purpose and in line with the strategic direction provided.
- Act as initial escalation point for Product/Process related RA CMC queries from within the organisation and from vendors for marketed products.
- Provision of RA CMC support for Due Diligence.
- Responsible for RA CMC focused agency negotiations and interactions, including scientific advice.
- Lead a team of permanent employees within CMC regulatory. Ensure team members have clear performance and development objectives and deliver assigned RA CMC objectives on their portfolio.
- Provide and drive the direction of the RA CMC service provided to the Mundipharma companies and partners by vendors.
- Scientific based degree
- Proven pharmaceutical experience in regulatory or technical CMC
- CMC technical experience
- Excellent knowledge of RA CMC in relation to global initial registrations and lifecycle management.
- Proven ability to drive efficient technical regulatory stewardship of products working in collaboration with internal and external partners.
- Strong organisation and problem solving skills.
- Self-motivated, driven with a positive attitude.
- Excellent communicator and collaborator with strong customer and stakeholder focus.
- Ability to effectively motivate and manage a team to deliver RA CMC objectives
- flexible benefits package
- opportunities for learning & development
- collaborative, inclusive work environment
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=> 'Director of Regulatory CMC.', 'vacancies' => null, 'job_type_id' => null, 'description' => null, 'pay_status' => 'Free', 'external_job_description' => 'ARA-M4-14<ul><li> Location: Cambridge (Home working with some travels to Cambridge when needed) </li><li> Job type: Permanent </li> At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. <p></p> We are looking for a CMC Director to efficiently manage and deliver the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Products across EU and ROW. The person will also be responsible for building and maintaining a strong collaborative partnership with products teams especially with team members from Tech Ops and Quality. 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Ensure team members have clear performance and development objectives and deliver assigned RA CMC objectives on their portfolio. </li><li> Provide and drive the direction of the RA CMC service provided to the Mundipharma companies and partners by vendors. </li></ul><b> Qualifications </b><ul><li> Scientific based degree </li><li> Proven pharmaceutical experience in regulatory or technical CMC </li><li> CMC technical experience </li><li> Excellent knowledge of RA CMC in relation to global initial registrations and lifecycle management. </li><li> Proven ability to drive efficient technical regulatory stewardship of products working in collaboration with internal and external partners. </li><li> Strong organisation and problem solving skills. </li><li> Self-motivated, driven with a positive attitude. </li><li> Excellent communicator and collaborator with strong customer and stakeholder focus. </li><li> Ability to effectively motivate and manage a team to deliver RA CMC objectives </li></ul><b> What we offer in return </b><ul><li> flexible benefits package </li><li> opportunities for learning & development </li><li> collaborative, inclusive work environment </li></ul> Diversity and inclusion <p></p> Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn't just the right thing, but also the smart thing to do, as we focus on making a positive difference for our customers and their patients. <p></p> About Mundipharma <p></p> Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe debilitating disease areas. 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Sales and marketing are the two best friends walking hand-in-hand to help you achieve this ultimate goal. If you are looking to set up your own business, develop and market your idea or if you are simply looking to get a job in the fast paced business environment, then this combined course is for you. This ultimate sales and marketing course wraps up four key topics into separate courses - traditional marketing, digital marketing, advertising and sales. It is an overview of everything you should know and be doing in order to get your idea, product or business discovered. The course takes you on a journey to explore these topics, learning key concepts and techniques and building a solid foundation of knowledge and practical experience as you work through the modules, teaching you how to make sure that people know, buy and love what you have to offer. <h4>What you will learn:</h4> <ul class="learn-mod"> <li>The fundamentals of Search Engine Optimisation and how to make sure that your content can be discovered by search engines</li> <li>What Web Analytics are and how they can help you see the effectiveness of your marketing campaigns.</li> <li>The key difference between marketing and advertising and why it is important to distinguish between both activities</li> <li>The anatomy of an advert and how knowing about message positioning can help you build a strong brand</li> <li>How to plan and execute a successful advertising campaign and why this is important for promoting your product or business</li> <li>What makes a piece of content go viral and how to use this for advertising purposes</li> <li>The psychology of selling and the theory behind the typical sales cycle</li> <li>How to become successful in sales and have people buy your products</li> </ul> <h4>Marketing Diploma</h4> The demand for high quality marketers is increasing exponentially and there has never been a better time to get into the field. Hundreds of new companies are incorporated every day in the world and to get their name heard, all of them need marketing. The Marketing Diploma explores the traditional methods and techniques used to promote and sell products and services. Beginning with the theoretical introduction to the four P’s of marketing, going through lessons focused on the practical ways to identify your potential client and their specific need, and wrapping up with step-by-step explanations of how to conduct a market research analysis, this course provides all the tools that a beginner in marketing may need in order to hone their skills. Stepping up the game, apart from fundamental knowledge, the course features advanced topics in marketing focused on the importance of building your own marketing plan and how it will help you boost the results from marketing. <h4>Digital Marketing Diploma</h4> The fundamentals of traditional marketing outlined in the Marketing Diploma are further expanded in the Digital Marketing Diploma course that looks specifically into promoting your products or services using the digital channels that are available today. The course touches on a variety of digital marketing tools and techniques. Mimicking the online behaviours of people, the course follows a logical flow - starting from the search engine and how to optimise content so the search engine can “understand” it and including practical advice on how to utilise social media and pay-per-click advertising to gather and drive traffic to your website. 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Sales and marketing are the two best friends walking hand-in-hand to help you achieve this ultimate goal. If you are looking to set up your own business, develop and market your idea or if you are simply looking to get a job in the fast paced business environment, then this combined course is for you. This ultimate sales and marketing course wraps up four key topics into separate courses - traditional marketing, digital marketing, advertising and sales. It is an overview of everything you should know and be doing in order to get your idea, product or business discovered. The course takes you on a journey to explore these topics, learning key concepts and techniques and building a solid foundation of knowledge and practical experience as you work through the modules, teaching you how to make sure that people know, buy and love what you have to offer. <h4>What you will learn:</h4> <ul class="learn-mod"> <li>The fundamentals of Search Engine Optimisation and how to make sure that your content can be discovered by search engines</li> <li>What Web Analytics are and how they can help you see the effectiveness of your marketing campaigns.</li> <li>The key difference between marketing and advertising and why it is important to distinguish between both activities</li> <li>The anatomy of an advert and how knowing about message positioning can help you build a strong brand</li> <li>How to plan and execute a successful advertising campaign and why this is important for promoting your product or business</li> <li>What makes a piece of content go viral and how to use this for advertising purposes</li> <li>The psychology of selling and the theory behind the typical sales cycle</li> <li>How to become successful in sales and have people buy your products</li> </ul> <h4>Marketing Diploma</h4> The demand for high quality marketers is increasing exponentially and there has never been a better time to get into the field. Hundreds of new companies are incorporated every day in the world and to get their name heard, all of them need marketing. The Marketing Diploma explores the traditional methods and techniques used to promote and sell products and services. Beginning with the theoretical introduction to the four P’s of marketing, going through lessons focused on the practical ways to identify your potential client and their specific need, and wrapping up with step-by-step explanations of how to conduct a market research analysis, this course provides all the tools that a beginner in marketing may need in order to hone their skills. Stepping up the game, apart from fundamental knowledge, the course features advanced topics in marketing focused on the importance of building your own marketing plan and how it will help you boost the results from marketing. <h4>Digital Marketing Diploma</h4> The fundamentals of traditional marketing outlined in the Marketing Diploma are further expanded in the Digital Marketing Diploma course that looks specifically into promoting your products or services using the digital channels that are available today. The course touches on a variety of digital marketing tools and techniques. Mimicking the online behaviours of people, the course follows a logical flow - starting from the search engine and how to optimise content so the search engine can “understand” it and including practical advice on how to utilise social media and pay-per-click advertising to gather and drive traffic to your website. But digital doesn’t end with search engines and social media channels, there is more than meets the eye and the course goes in-depth to discuss how to analyse data using web analytics as well as how to plan and launch email and mobile campaigns. It is an all-round primer providing the “know how” to anyone who wants to be successful in the digital 21st century. <h4>Advertising Diploma</h4> People often explain digital marketing as just one slice of the marketing pie and using the same logic, advertising is another slice of the same pie, perhaps an even bigger one. The Advertising Diploma course is a brief overview of traditional advertising, focusing on practical methods and working knowledge. Strategies, planning and budgeting are the crucial components of a successful advertising campaign and the course explores all of them and more - it also examines what makes an ad go viral as well as the most common mistakes in advertising that should be avoided at all costs. Finally, the Advertising Diploma looks at the various abbreviations and UK legislation in regards to advertising and discusses the vast opportunities that online and print advertising can offer. <h4>Sales Diploma</h4> Marketing and advertising efforts do pay off and the result is the increased interest from potential clients as they are attracted by your brand and message. The next and perhaps the most important step is to help them reach the decision to actually buy your product or service by employing a variety of selling techniques. It has been proven that there must be at least five different contacts with the client before they reach the decision to buy as selling is an art of engagement. The Sales Diploma gives away the secrets of a successful salesperson in that it shows you the stages of the sales process and teaches you how to overcome objections that stand in the way of the deal. The Sales Diploma is a practical guide for anyone looking to gain the skills of negotiation and persuasion, the key skills for selling. It also looks at effective ways to write proposals, prospect clients and lead generation. <h4>The Benefits of the combined Sales and Marketing Course</h4> There are a number of major benefits associated with this special Sales & Marketing Course in that it does provide you with comprehensive knowledge to build your marketing funnel and use sales techniques to convert potential leads into paying customers. Secure the wellbeing of your business by learning all there is to know about sales, marketing and advertising and how you can become an expert in promoting and selling products and services. 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We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. <p></p> We are looking for a CMC Director to efficiently manage and deliver the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Products across EU and ROW. The person will also be responsible for building and maintaining a strong collaborative partnership with products teams especially with team members from Tech Ops and Quality. 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Ensure team members have clear performance and development objectives and deliver assigned RA CMC objectives on their portfolio. </li><li> Provide and drive the direction of the RA CMC service provided to the Mundipharma companies and partners by vendors. </li></ul><b> Qualifications </b><ul><li> Scientific based degree </li><li> Proven pharmaceutical experience in regulatory or technical CMC </li><li> CMC technical experience </li><li> Excellent knowledge of RA CMC in relation to global initial registrations and lifecycle management. </li><li> Proven ability to drive efficient technical regulatory stewardship of products working in collaboration with internal and external partners. </li><li> Strong organisation and problem solving skills. </li><li> Self-motivated, driven with a positive attitude. </li><li> Excellent communicator and collaborator with strong customer and stakeholder focus. </li><li> Ability to effectively motivate and manage a team to deliver RA CMC objectives </li></ul><b> What we offer in return </b><ul><li> flexible benefits package </li><li> opportunities for learning & development </li><li> collaborative, inclusive work environment </li></ul> Diversity and inclusion <p></p> Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. 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الشركة المعلنة عن الوظيفة
Mundipharma
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