Работа в Москве, вакансия - Regulatory Affairs Manager/ Менеджер по регуляторным вопросам • Москва - id454

Regulatory Affairs Manager/ Менеджер по регуляторным вопросам

This position reports to Regulatory Affairs Lead.

Purpose: Manage and provide regulatory support for registration and maintenance of the products in the assigned Therapeutic areas (aTAs) on territory of EAEU and CIS.

Responsibilities:

Advance Product Support in aTAs: Submissions & Approvals:

• Coordinate handling of company core date sheet (CCDS) updates
• Review promotional, non-promotional materials per agreed guidelines & within required timeframe
• Provide support in defining and implementing regulatory aTAs strategy
• Keep abreast of emerging legislation, local or international, related to registration and highlight the potential impact on the business
• Gather a thorough knowledge of the registration files and all related company product documentation. Keep up to date on products in aTAs
• Participation in Local brand-teams for aTAs and providing regulatory support for Commercial and Sales force
• Create, review and sign registration submission dossiers prior the submission ensuring compliance of the dossier with local and corporate requirements
• Ensure that all Regulatory submissions (new marketing authorisation applications, EAEU harmonizations, EAEU recognition, renewals, variations, notifications) are prepared and filed in a timely manner for all registered and new aTAs products in EAEU/CIS countries
• Gain Regulatory Authority approval for Marketing Authorisations for new products
• Maintain existing aTAs’ product Marketing Authorisations and gain Regulatory Authority approval of variations (amendments) to these authorizations as required
• Manage any further information requests from local Regulatory Authority in a timely manner, ensuring local authority’s expectations are accurately translated for AbbVie Area Regulatory. Submission of any subsequent responses/product documentation updates to local Regulatory Authority
• Maintain actual status for all submissions and approvals in aTAs in AbbVie RA electronical systems (e.g., AMP, AMS, Cosmos etc.)
• Review product labeling in accordance with legal and regulatory requirements ensure that all labeling information is accurate, updated and approved by both Company and relevant Regulatory Authority in accordance with the Company policies and local regulations
• Create Product Normative Documents in accordance with Company’s analytical guidelines and local regulatory requirements ensure that all information is accurate, updated and approved by both Company and relevant Regulatory Authority
• Provide and/ or manage translations of the documents, as required
• Provide appropriate amounts and list of samples, reference standards, reagents and equipment required for pre-submission and registration testing of drug products
• Provide necessary support in local pre-submission laboratory testing, if needed
• Participate in packaging projects implementation within agreed timeframe, including development with third parties of updated artwork for cartons, labels and leaflets in accordance with Company requirements and local regulations
• Assist in development and updating of local standard operational procedures
• Improve professional skills and knowledge attend Company’s and external educational events to increase qualification.

Regulatory Excellence:

• Cooperate and liaise with manufacturing sites, corporate head-office, Area and other Company departments
• Establish and maintain good relationships with all involved regulatory institutions in EAEU/CIS countries
• Identify and track changes/trends in regulatory approaches and practices in EAEU/CIS and communicate them within the Company.

Regulatory support for other Company functions: Sales and Marketing, Quality Assurance Department, GMP inspections, Medical Affairs department, Regional/global functions.

People/Talent:

• Provide training of newcomers on relevant Regulatory processes and systems when necessary.

Requirements:

• University degree in Pharmacy, Chemistry or Life Sciences
• Minimum of 3 years’ Regulatory Affairs experience in an associated company within the Healthcare Industry
• Adequate judgment, strong communication and negotiating skills
• Teamwork skills
• Comprehensive knowledge of local Regulatory Affairs requirements
• Able to work with big volumes of documents and texts
• Attentive to details, responsible and well-organized
• Fluency in English both verbal and written
• Good presentation skills
• Efficient Computer Skills.

Conditions:

• Comfortable office (hybrid work format)
• Medical insurance, meal and mobile allowance, annual bonus
• The possibility of professional and career development.