Regulatory Affairs Manager - Dutch And English

Belgium  ‐ Onsite
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Keywords

Description

Regulatory Affairs Manager is required by our client, one of the world`s largest pharmaceutical and Biotechnology companies to join their large Research and Manufacturing facility in Belgium on an interim basis. This contract will run initially until the end of 2013 with scope for further extension.

Essential functions include, but are not limited to:
-For assigned products, ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities and - as applicable - to the EMA.
-Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
-For assigned products ensures timely, accurate and compliant labelling translations and artwork preparation.
-For assigned products and tasks, stays updated on recent company legislation and relevant EU and local regulations and guidelines.
-To collaborate with the local Business Development team to support regulatory strategy for the launch of new products.
-Maintains a positive relationship with internal and external regulatory contacts. GRSPS on sub-regional, regional and global level, internal regulatory authorities, as well as other key players in the regulatory environment.
-Acts as substitute for Regulatory Affairs Director as appropriate.

MAJOR ACTIVITIES
New MA applications for assigned products:
-Performs timely and correct submission and approval of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing and external affairs departments, GRSPS on sub-regional, regional and global level, as well as with local regulatory authorities as appropriate, depending on procedure type. Coordinate and implement early access programs with the Agency.
-Track process and manage answers to objections from the Agency on products registration and major new indications, involving negotiations to achieve best conditions.
-Maintenance of licenses for assigned products:
-Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing that necessary activities, including variations, renewals, with a high standard and within the agreed timeframes and communicate approvals to stakeholders through the correct processes.

Compliance:
-For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians` circulars, packaging material and other applicable regulatory documents according to organisational and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
-Ensure that all internal customers receive relevant information with regard to the regulatory status of the assigned products.
-Ensures the correct and proper utilization of AMS Blue to generate mock-up artwork and to implement revisions to artwork.
-Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
-Ensures that files and archives related to Regulatory affairs are kept updated and complete.
-Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
-Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.

Labelling and artwork:
-Ensures high quality translations and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents.
-Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.

Cross-functional activities:
-Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners as appropriate.
-Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
-Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.
Regulatory environment:
-Keeps abreast of local and international laws.
-Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders, and in concurrence with the EU Regulatory Policy lead.
-For new regulations, identifies and tracks changes/trends that might impact the business.
-Participates in task forces of Pharmaceutical Industry/Agency as back up of the Manager.

LOCAL REQUIREMENTS
-To create an efficient working environment; to develop a good team spirit with the direct RA partner, team members and other internal stakeholders.



Quality:
-Ensures handling of customer complaints and product recalls according to company standards and local procedure. Closely cooperates with Quality Responsible Person (QP, MMD), Customer Service and/or PhV.

Pricing and Reimbursement:
-To collaborate with external affairs on pricing and reimbursement strategy, involving active participation to meetings like RPR (Registration, Price and Reimbursement; Flow team etc....).

Skills Required:
-Must hold a MS degree in pharmacy or other life science
-Extensive experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies.
-Must be fluent in English and Dutch.
-The incumbent must be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products.
-Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.
-The incumbent should possess a meticulous attention to detail, and be flexible enough to successfully handle conflicting time pressures and a large volume of work.
-A mature and disciplined approach to work is essential as is the ability to coordinate the work of others.
-The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties.
-The incumbent must demonstrate proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet.
-A sound appreciation of the interactions and relationships of the department with other groups internally is expected.
-Must have client oriented approach and work according to the leadership vision.
Start date
n.a
From
Quanta Consultancy Services
Published at
16.08.2013
Contact person:
Lee Mitchell
Project ID:
584583
Contract type
Freelance
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