Location: Europe, Middle East & Africa-Sweden-Stockholm-Stoc
Closing Date: 07 Dec 16
Type: Full Time
Salary (£): On Application
PPD has a new exciting opportunity for a Regulatory Affairs Manager, to join our Global Regulatory Affairs team. The position is based in the Nordic Region and can be home or office based. In this role, you will act as subject matter expert in providing regulatory strategy advice to internal and external clients. Leads projects to create and enhance innovative solutions for product development from preclinical through to registration and product optimization. ...
PPD has a new exciting opportunity for a Regulatory Affairs Manager, to join our Global Regulatory Affairs team. The position is based in the Nordic Region and can be home or office based.
In this role, you will act as subject matter expert in providing regulatory strategy advice to internal and external clients. Leads projects to create and enhance innovative solutions for product development from preclinical through to registration and product optimization. Partners with other departments to collate information in order to secure new business.
Reviews and provides technical advice to prepare regulatory submissions.
• Manages project budgeting and forecasting functions.
• Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
• Assists Business Development in pricing and securing new business by making presentations to clients, develops proposal texts and budgets in collaboration with Contracts and Proposal Development.
• Matrix manages other individuals assigned to support projects of responsibility. Provides guidance, training, coaching and mentorship to other Regulatory Affairs personnel through liaison with the training manager. Deputizes for functional manager as necessary.
• Provides PPD staff with up-to-date legislation and guidance as it becomes available and ensures compliance with relevant organizational and Regulatory Affairs SOPs and WPDs.
• Participates in launch meetings, review meetings and project team meetings.
Education 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
Proven knowledge of Regulatory Affairs Procedures in the Nordic Region
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.
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