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05.06.2020
REGULATORY AFFAIRS ASSISTANT, ТОРО ГРУПС ООД  Вижте визитка на компанията
Месторабота София; Постоянна работа; Непълно работно време; Подходяща и за студенти; Подходяща и за кандидати с малък или без опит
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REGULATORY AFFAIRS ASSISTANT

For our client - Abbvie, a global biopharmaceutical company, we are looking for a driven professional for the mission of:

REGULATORY AFFAIRS ASSISTANT


Main purpose of the position:

Support Regulatory Affairs for AbbVie Bulgaria for all AbbVie Pharmaceutical products in a way that meets all statutory, quality and business requirements within the overall strategy and objectives of AbbVie.


MAIN RESPONSIBILITIES:

Advance Pipeline/Marketed Product Support: Submissions, Renewals & Approvals:

- Assist in preparation and filing of regulatory submissions in a timely manner for all Company products marketed and/or registered in Bulgaria or new products intended to be marketed in Bulgaria. Follow up all steps for authorization/approval of these submissions.
- Assist maintenance of existing pharmaceutical product marketing authorisations and monitor regulatory authority approval for the variations of these authorizations.
- Preparation and filling of the respective documentation related to all AbbVie promotional materials and donation procedures.
- Support all RA activities related to sampling procedures.
- Help in translation and preparation of SmPCs, PILs and labeling in accordance with legal and regulatory requirements;
- Provide and/ or manage required translation support.
- Manage training and communications to local Marketing, Sales and Medical personnel relating to SmPC/PIL changes prior to their implementation.
- Maintain internal regulatory files and product database in good chronological order.
- Maintain RA tracking systems.
- Responsible for regulatory document administration – updating lists and fillings; scanning and archiving regulatory correspondence; process organizational and administrative routine tasks for the RA department.
- Provide technical support to Regulatory Affairs Manager and Regulatory Affairs Specialist.

Compliance/Training:

- Keep the assigned regulatory databases on the server up to date.
- Ensure compliance with statutory local, regional, and AbbVie corporate regulations.
- Responsible for execution of the training and education on a timely manner.

Finance: Budget/Headcount:

- Monthly expense report



REQUIREMENTS:

- University degree (business or scientific), preferably pharmacy, life sciences, chemistry or equivalent. University students of pharmacy, life sciences, chemistry, or equivalent will also be considered for the role.
- Proficiency in written / verbal English language.
- Computer literacy.


PERSONAL CHARACTERISTICS:

- Thorough attention to detail and high standards of accuracy.
- Solution mindset, good problem-solving skills, and the ability to work to tight deadlines.
- Effective communications skills.
- Team player with the ability to work cross functionally.
- Good organizational skills
- Creative self-starter capable of working autonomously, with an interest in developing this role and continued training.


The company offers:
- An opportunity to learn and develop oneself professionally in a leading international organization.
- Part-time role with 20 work hours per week
- Competitive compensation


If you’re interested in the advertised opportunity please send us your CV. Only selected candidates will be invited for an interview.

License № 2418 from 18.12.2017
Запознат съм с Политика за защита на лични данни на ТОРО ГРУПС ООД


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ТОРО ГРУПС ООД  Известие за нови обяви
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