Lead local regulatory activities, ensure compliance with regulations, prepare submission documents, manage translations, and maintain relationships with regulatory authorities.
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Job Description
ROLE OBJECTIVE
Align with expected objectives skills and competencies:
ACCOUNTABILITIES
Leadership
Regulatory Affairs Manager:
Experience and Education
Locations
Bratislava, Slovakia
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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
Locations
Bratislava, Slovakia
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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