Senior Regulatory Affairs Manager (CMC)
Senior Regulatory Affairs CMC Manager - Cambridge
A forward-thinking, global pharmaceutical organisation, celebrated for employee satisfaction, stunning offices and international success has now opened a position for an expert CMC Senior Regulatory Affairs Manager. Aside from the company's glowing reputation, a highly competitive salary and benefits package has been extended for a candidate demonstrating the appropriate skill set, and the same entrepreneurial spirit that resounds throughout the business.
The right candidate should have broad experience of Regulatory Affairs, across Europe and the International markets, specialising in CMC, pre & post marketing activities.
What the role involves:
oThoroughly preparing compliant CMC documentation to a high standard in order to support clinical trial applications, marketing authorisation applications and product life cycle maintenance through variations and renewals in accordance with good regulatory practice.
oUsing strong scientific knowledge to advise on regulatory strategy
oProject manage and lead tasks
oProvide line management support in the form of mentoring, providing guidance and advice to junior members of staff. You would be responsible for a small team of between 2-4 people, for whom you would be involved in training and development activities, including evaluating their progress and addressing any issues identified accordingly.
oBe responsible for the content of module 2.3 (QOS), and the expert report.
oDue diligence and business development projects for the CMC Regulatory department
The ideal candidate:
oStrong and diverse Regulatory experience, with a minimum of 5 years CMC.
oSome prior experience of acting as a Line Manager
oKnowledge of medical devices, biologics, biosimilars, New Chemical Entities, consumer health and Oncology is highly desirable
oExperience of CP, DCP and MRP, as well as relevant experience in international markets including Latin America, Asia Pacific, Europe and Middle East and Africa regions.
oExperience of a CMO environment, and knowledge of drug development and manufacturing is highly desirable
oAble to work in a fast paced environment, whilst meeting strict deadlines and delivering large complex studies
oAble to manage and work effectively in a team, whilst being highly capable of independent working
oBe a positive person, flexible and passionate with a strong sense of personal integrity and honesty that reflects the company's values
This organisation has an outstanding reputation in the industry. If you would like your career to flourish within a friendly and supportive team, in a beautiful location and receive a highly competitive salary at the same time, apply for this opportunity. For further details, please ring Emilie Francis on 0121 616 3477, or alternatively email at email@example.com.
Stevenage, Cambridge, Regulatory Affairs, Manager, Senior, Oncology, CMC, LATAM, APAC, MEA, Global, MAAs, Lifecycle, Regulatory Strategy, Permanent, Consumer Healthcare
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