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Regulatory Affairs manager

International Pharmaceutical company, Representative office in Belarus

Required work experience: 3-5 years

Full time employee, full day

JOB’S MISSION:

The Regulatory Affairs Manager - BY

• Is responsible for managing all regulatory activities for commercial products and development projects including new registrations, renewals, new indications and variations for pharmaceutical, medical device and nutritional product portfolio in Belarus and other assigned CIS/EAEU countries. Assigned countries may be subject to regrouping.

• Provides expertise for anticipation of regulatory trends and the effective development of local internal processes in line with EMEA strategies and SOPs, ensuring these internal processes and all activities meet local regulation, law, and codes.

• Acts as the local link with external partners and internal stakeholders for RA, QA, SV and Compliance, as needed. Work in coordination with Int.RA (Associate Director International RA, line management) and rest of the team and in closed contact with local the related functions (Country Manager GM, dotted management).

KEY RESPONSIBILITIES & ACCOUNTABILITIES

The RA manager - BY

1. Is Responsible for planning and managing of all regulatory affairs activities according to priorities and resources available, assuring compliance and further development of portfolio in the assigned countries a Independent preparation of regulatory plans and strategies for implementation of regulatory applications and responses effectively pursuing approvals in accordance with regulatory requirements and company goals.

2. Manage regulatory lifecycle for assigned products. Here for the RA Manager BY conducts registrations, renewals and variations to the registration documents on the Company`s products

Job Description

1.Staying up-to-date on current regulatory requirements,

(Including medicinal products, medical devices and nutritional products) in line with the agreed schedule working together with local regulatory affairs members / consultants in and for the assigned countries.

Thus includes: ii. Provide guidance to EU development teams in regards to current regulatory requirements and policies affecting registrations of assigned portfolio.

2. Review and give regulatory feedback on Change Control proposals and evaluations

3. Manage and execute the preparation of all necessary regulatory documentation related to registration and maintenance of the local (national) regulatory dossiers

4. Coordinating compilation and maintenance of relevant Product Information (SmPC, labelling etc.) for products of assigned IntRA countries together with other related departments.

5. Preparing responses to deficiency letters together with the relevant contacts,

6. Informing about received marketing authorization approvals and changes in-house to relevant external partners via e-mail and to relevant Company departments via Company e-Tools (databases), by using Company work folders, Cloud and other electronic tools, keeping Company databases (TrackWise for RA and QA, GLAMS and Veeva) and other electronic databases updated in timely manner and archive documentation, following in all activities the rules and SOPs and Working Instructions of Int.RA, QA and SV EMEA Region.

7. To the assigned portfolio, the RA manager BY controls and monitors all the RA-processes (e.g.: registration, renewal, LiC and variation procedures) as well as launch preparation procedures (e.g.: artwork development, approved document/information provision). Here for the RA-manager BY Cooperate with internal and external partners and authorities to maintain MAs. This work includes organizing import licences for samples needed for regulatory purposes.

8. Prepare and review of secondary packaging materials mock-up/artwork to ensure compliance with regulatory approved texts in English, Russian and possible national language(s).

9. Working in a project organization and support international cross-functional product development teams as assigned.

10. Reporting of the status and plans for regulatory activities for the assigned marketing authorizations to the Leader of IntRA department.

11. RA Expertise ensuring up-to-date changes in regulatory legislation and guidelines locally a making sure that products and related documentation comply with the requirements of local Regulatory Bodies, local legislation and company rules and standards

12.Maintaining current knowledge of local regulatory and legislative requirements (regulations, guides, etc.) and trends in the local country to ensure that technical support on all regulatory related matters is provided

13. Establishing efficient cooperation with respective National Authorities and public organizations, related to the registration process

14. Act as RA link to QA, Vigilance a. Informing QP and Quality Assurance in case of any quality concerns from authorities (queries from competent authorities), for assuring QA compliance within Company. Coordinates and prepares applications for national or EAEU GMP inspections performed by Belarussian Authority.

15. Supports the Vigilance unit as defined in Company policy. Conducting local Pharmacovigilance activities as requested, needed and agreed for assuring Safety to Company patients: i. Inform QPPV and Pharmacovigilance Unit in case of any safety related concerns from authorities (queries from competent authorities, emerging safety issues, changes in the safety information)

16. Requesting and submission of PSURs and RMPs prepared by Pharmacovigilance Unit to regulatory authorities

PROFILE

EDUCATION

Essential

• Relevant Pharmaceutical, Medical or life science university degree

• Language: Strong command / fluent in Business English and local language (written and oral).

Desirable

• Basic knowledge of GxP's regulation, especially GMP/ GDP and Medical device regulation

• Language: Command of other CIS languages, English intermediate

• Minimum 3-5 years Regulatory Affairs experience in Belarus

• Experience in local Regulatory Affairs duties in CIS region

EXPERIENCE

Essential

• Minimum 3-5 years Regulatory Affairs experience in Belarus

• Experience in local Regulatory Affairs duties in CIS region

• Knowledge on local (Belarus and CIS) compliance regulations and related processes

Desirable

• Experience in Compliance responsibilities

• Experience in QA and Vigilance responsibilities

• RA-Tools: Familiar with document management and archiving practices

FUNCTIONAL COMPETENCIES

Essential

• Delivery focus and solution oriented

• Team player. Ability to motivate individuals and demonstrate organizational influence

• Strong written & oral communication and presentation skills (in English)