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02.09.2020
★★★★★ Regulatory Affairs Specialist, Бакстер България ЕООД
Месторабота София, Work from home; Постоянна работа; Пълно работно време; Езици: Английски
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Regulatory Affairs Specialist

SUMMARY:
 Responsible for the implementation of regulatory strategies, obtain and maintain marketing authorizations for products and provides communication of general regulatory requirements in support of licensing of Baxter’s products.
 Contact point for local regulatory authorities regarding products in Bulgaria
 Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
 Establish appropriate communication within RA and with other functions
 Perform regulatory gap analysis and propose solutions
 Develop and document sound regulatory decisions and justifications
 Ensure regulatory strategies are aligned with project teams and country business objectives
 Review promotional material and SOPs for compliance with local and global regulations
 Partners with country business in country goals achievement
 Represent RA function on assigned cross-functional project teams


ESSENTIAL DUTIES AND RESPONSIBILITIES:

REGULATORY AFFAIRS
 Maintain appropriate positive contacts with regulatory officials to enable the clear understanding of requirements and the defence of Baxter positions when appropriate.
 Perform and/or review the translation of labelling
 Review promotional materials for use when applicable
 Prepares regulatory applications of medicines and medical devices to achieve product licensing and registration and maintains current registrations. This involves the following tasks:
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Prepare, review, and approve labelling and SOP’s
• Provide regulatory advice to project teams.
• Respond to regulatory authorities’ questions within strict deadlines.
• Maintain regulatory files in a format consistent with requirements
• Maintain and update existing regulatory authorizations.
• Represent Regulatory Affairs in project teams
• Review promotional material for compliance with local regulations
 PSURs:
• Schedule annually local PSUR if needed.
• Submit PSURs to local authority if appropriate.

2. REGULATORY COMPLIANCE
Ensure that relevant policies and procedures established in the country are enforced and that these
procedures comply with the requirements of local law and regulations, specifically related to:

• release for country distribution.
• labelling and advertising of products, including national language requirements.

B. Keep track of current regulatory trends in the country.


JOB REQUIREMENTS:

Education
Bachelor's degree or country equivalent in pharmacy or related scientific discipline. Higher degree/PhD will be an advantage. Fluent in English and Bulgarian. Basic computer proficiency.

Experience
Minimum two years of experience
Field of expertise: RA in medtech/ pharmaceutical company, CRO or similar organisation.

Functional requirements & competencies:
• Sound basis of regulatory knowledge
• Scientific knowledge
• Strong oral and written communication skills
• Demonstrated interpersonal skills including strong negotiation skills
• Ability to independently identify compliance risks and escalate when necessary



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