Location: Europe, Middle East & Africa-UK-England-Cambridge,
Closing Date: 21 Jan 17
Type: Full Time
Salary (£): On Application
PPD has an exciting new opportunity for a Regulatory Affairs Manager, to join our Global Regulatory Affairs department. This position can be based anywhere in EMEA. PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. ...
PPD has an exciting new opportunity for a Regulatory Affairs Manager, to join our Global Regulatory Affairs department. This position can be based anywhere in EMEA.
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.
At PPD, Regulatory Affairs Provides innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. Provides regulatory advice and carries out projects in the provision of regulatory affairs services. Acts as liaison with internal and external clients in the provision and marketing of these services. Works with the Regulatory Affairs Management to perform the day to day operational aspects of the department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature.
Are you ready to take your career to the next level?
Major responsibilities in this role include:
-Overall responsibility for a specific client product with an expectation to build long term knowledge and become the product champion
-Key member of client’s regulatory submissions management unit, working with the Programme Director and Manager to ensure client receives regular reports/updates as necessary
-Lead a team of Regulatory Specialists to deliver global post-approval submissions
-Liaise with internal/external stakeholders and experts to deliver quality submissions and ensure adherence to submission/approval work plan.
-Ensure Regulatory Submission Specialists have prescribed details to manage compilation of dossiers
The ideal candidate will have strong project management and strategic thinking skills, a proactive style, the ability to use initiative, and possess excellent organization and customer awareness skills.
Education and Experience:
Degree in Pharmacy, Medicine or Life Sciences and several years of relevant regulatory experience regionally/globally,
OR equivalent combination of education, training, & experience
Knowledge, Skills and Abilities:
Knowledge and awareness of regulatory applications and procedures for a wide range of products (chemical drugs, biologics, medical device)
Project management knowledge and experience
Client/Vendor relationship management
English language as well as local language where applicable
Attention to detail and quality of documentation
Good interpersonal skills
Effective oral and written communication skills
Excellent decision making, organizational and planning skills
Excellent negotiation skills
Ability to work independently
Expertise of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
Analytical and investigative skills
Ability to interpret data
Expert knowledge of ICH and other global regulatory guidelines
Expertise in at least one of the specialty areas: product lifecycle management submissions, CMC authoring, Labelling, Publishing, new registrations in Emerging Markets/International
Ability to act as liaison with other departments
Knowledge of budgeting and forecasting
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