Regulatory Affairs Manager SK

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Job Description

ROLE OBJECTIVE

Align with expected objectives skills and competencies:

• Act as a local responsible person for RA
• Lead and secure local regulatory activities
• Prepare documentation for and drive local regulatory submission processes
• Ensure proper management of registered drugs with regards to regulatory maintenance activities

ACCOUNTABILITIES

Leadership

• Represent RA at departmental meetings and closely co-operate with other functions (PV, QA, Market Access, Sales, Marketing and Medical Affairs)

Regulatory Affairs Manager:

• Lead and secure local regulatory activities: new product authorizations, variations and renewals for all already authorized products
• Ensure that Takeda meets the regulatory requirements of the relevant authorities (including also but not limited to RMPs, blue-box-requirements, PSUR submission, etc).
• Prepare documentation and drive local regulatory submission processes (new applications, variations, notifications, renewals, transfers, etc) in alignment with launch strategy & launch plan and ensure timely and adequate regulatory submission/approval.
• Prepare documents for eCTD creation and manage eCTD preparation
• Prepare/manage translations for SmPC, PIL and product labelling and manage their distribution to key stakeholders within the company
• Translation of DHPC letter to local language and HA notification
• Artworks management
• Review content of local aRMM materials and provide comments, if necessary
• Establish and enhance relationships/communication with regulatory authorities
• Ensure that Takeda corporate standards are in alignment with local regulatory affairs and respond adequately to the functional leads at Headquarters.
• Keep update knowledge about Regulatory regulation and procedures.
• Keep record of Regulatory activity and updates required files and databases and prepares reports
• Proper archiving of the regulatory documentation
• Prepare local Procedures relevant for Regulatory affairs and provides regulatory input to other areas e.g. SOPs
• Review promo-materials from regulatory point of view if required
• Notify and keep the records of the Medical Devices according to local requirements
• Comply with companies Compliance Policies and Quality standards

Experience and Education

• University Degree – preferably in Medicine, Pharmacy, Veterinary, Chemistry or Nature Sciencies
• Advanced knowledge of local regulatory requirements
• In-depth knowledge of applicable regulatory affairs laws, regulations and policies, both national and international
• At least 1 year of experience in Regulatory in Pharmaceutical Industry
• Knowledge of Medicinal Product development process
• Knowledge of storage and distribution process of Medical Devices
• Fluent English, able to attend and discuss presentation of projects.
• Experience in project management
• Articulate, positive, work ethic, confident, enthusiastic, flexible, team player.
• Good interaction with and influencing of others, both internally and externally
• Ability to handle multiple tasks and good prioritizing ability

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