Regulatory Affairs Manager, Nordic Region - Home Based-133720
Nr ref.: /JOBS.pl
PPD has a new exciting opportunity for a Regulatory Affairs Professional, to join our Global Regulatory Affairs team in EMEA. The position is based in the Nordic Region and can be home or office based.
In this role, you will provide innovative solutions and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization.
Major Responsibilities include:
-Reviews and provides technical advice to prepare regulatory submissions
-Provides regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products
-Provides project specific GRA strategy, technical expertise and co-ordination oversight for key client's projects
-Ensures quality performance for key/managed projects
-Liaises with PPD globally to support global projects
-Assists business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure
-Contributes to development & implementation of Global/regional function/plans
-Participates as required in project Launch Meetings, Review Meetings and Project Team meetingsQualificationsEducation and Experience:
Several years of regulatory affairs experience which provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience Proven leadership skills
Knowledge, Skills and Abilities: -Excellent interpersonal skills -Effective oral and written communication skills -Excellent organizational and planning skills -Good negotiation skills -Ability to work on own initiative -Proven ability to work effectively in a team environment -Ability to motivate and integrate teams and teach/mentor team members -Good knowledge of Nordics Regulatory Affairs Procedures for Clinical Trial Authorization, licensing, lifecycle management -Expert knowledge of ICH and other global regulatory guidelines -In-depth knowledge in one of the specialist areas; preclinical, clinical, or CMC, etc -Ability to discipline and reward employees and perform timely, effective performance evaluations -Good judgement and decision-making skills -Ability to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, etc) -Knowledge of budgeting and forecasting
The successful candidate will ideally be educated to degree level in Pharmacy or Life Sciences, a higher qualification in a relevant subject or post graduate courses Regulatory Affairs would be an advantage. Alternatively you will have the equivalent combination of education, training and experience that provides you with the required knowledge skills and abilities.
HOW TO APPLY:
Please submit your CV in English.
Registration on our website will also give you the opportunity to be considered for other positions if this one is not the most appropriate for your qualifications and experience. This is an ongoing search. Suitable candidates will be contacted accordingly.