MSD Country Regulatory Affairs Lead & 

Serbia, Central Serbia, Stari Grad Urban Municipality 

150969540

Job Description

Basic Functions & Responsibility:

• Has the overall responsibility for Regulatory in Serbia & Montenegro and for managing related issues according to ethics and standards.
• Responsible for people management of Regulatory personnel in Serbia & Montenegro and provides clear leadership for the Regulatory group. Secures appropriate career development for the staff and is responsible for keeping the Regulatory group scientifically and legally updated within the Regulatory area.
• Acts business oriented in terms of Regulatory Affairs advice during product development, as well as to get the best authorized profile, to put the product in the market in the shortest period.
• Ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to the local authorities, designing an appropriate local ad-hoc action plan, as necessary.
• Ensures maintenance of authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• For assigned products ensures timely, accurate and compliant labelling translations and artwork preparation.
• Stays updated on late pipeline filings, relevant EU and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
• Participates in task forces of Agency/Pharmaceutical Industry for new regulations and implementation of new ones.
• Works alongside the BD, locally, regionally, and globally, to support business initiatives in sub region.
• Maintains a positive relationship with internal and external regulatory contacts. GRACS on sub-regional, regional, and global level, EUQPPV and GCS&PV are the main contact points within the company. Acts as primary point of local regulatory agency contact for the company in case of any urgent regulatory agency requests. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
• Responsible for regulatory affairs activities oversight/coordination & E2E compliance in Montenegro (applicable local third-party distribution model).

Major Activities:

New MA applications

• Ensures timely and correct submission and approval of new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, marketing, external affairs departments, outcomes research, market access, on sub-regional, regional and global level, as well as with local regulatory authorities as appropriate, depending on procedure type. Coordinates and implements early access programs with the Agency. Tracks process and manages answers to objections from the Agency on products registration and major new indications, involving negotiations to achieve best conditions.
• Designs and leads local action plans for new products, involving selection and regulatory training of external experts, heading strategy, and closely interacting with the Agency and Advisory Committee members, with continuous interface with RAE.

Maintenance of licenses

• Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through ensuring that necessary activities, including variations and renewals, are carried out with a high standard and within the agreed timeframes and that all approvals are communicated to stakeholders through the correct processes.
• For major new indications, designs and leads local action plans as above mentioned for new MA applications.

Compliance

• Ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to local standards. Keeps informed to ensure that Prescribing Information is implemented within the correct timeframes for compliance.
• Ensures that all internal customers receive relevant information with regard to the regulatory status of the products.
• Ensures the correct and proper utilization of Artwork Management System to generate mock-up artwork and to implement revisions to artwork in due time.
• Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
• Ensures that files and archives related to Regulatory are kept updated and complete.
• Ensures establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
• Ensures that updated regulatory documentation is implemented within required timings according to Agency requirements and in-house guidance.
• Provides regulatory representation for GCP and PhV Inspection teams and ensure that the regulatory component of these inspections is addressed.

Labeling and artwork

• Ensures high quality translations and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents.
• Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.

Cross-functional activities

• Obtains early information about new studies to be able to advice on Clinical Trial Applications and study planning as appropriate to the local GCTO group responsible for Clinical Trials.
• Ensures adequate support to other functions to enable compliance in areas related to regulatory.
• Participates, provides active input and lead if the case the local & Balkan Medical Governance.
• Gives strategic regulatory advice to maximize best positioning of products and company business.
• Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners as appropriate.
• Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
• Gives input of products under development (Phase IIb III) or new major indications, in terms of comparator agents, future prescribing and dispensing conditions, and potential best pricing and reimbursement conditions.
• Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.
• Participates and provides active input in Regulatory affairs/Quality/Customer service meetings.
• Provides training on regulatory (processes, timing etc.) to subsidiary members, as applicable.
• Participates in work-streams involving regulatory topics, as requested.

Regulatory policy & environment

• Retains accountability for following functional responsibilities that can be assigned to team members
• Keeps abreast of local and international laws, collects relevant publicly available regulatory information, provides insights, and responds to consultations on proposed national regulatory guidance, as appropriate, and communicates final regulatory guidance for awareness and impact assessment, in cooperation with Global Regulatory Policy.
• Advocates for therapeutic areas/local positions on regulatory issues and trends internally (cross-functional internal business partners including GCTO, market access, policy etc.), and externally (Agency, Industry Association) contributing to a broader policy platform, and through active participation in the regulatory work of the local Pharmaceutical Industry Association and task forces with the Agency, the incumbent seeks alignment of industry position with interests.
• Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization, and other stakeholders, and in concurrence with the EU Regulatory Policy head.
• Participates in internal regulatory policy managers' meetings at sub-regional and regional level and related regulatory workgroups on selected issues.

Manage RA team

• Sets up priorities, organizes, oversees, and monitors team's activities, towards division's and country's objectives achievement in compliance with policies and standards.
• Ensures that staff is trained for their proper use of internal regulatory systems.
• Through attendance to courses/workshops ensures that staff is appropriated updated on new legislations, requirements on Regulatory.
• Manages, coaches, and develops talent. Maintains a scientific knowledge and expertise for therapeutic areas.
• Fosters a positive team spirit of the staff.
• Establishes a regular system of communication of the department to update information on the status of main activities and mainly to share experiences, discuss strategies and put in common lessons to be learned.
• Administers the departmental budget.

Requirements:

• Closely cooperates with Quality Responsible Person (QRP) / Quality Contact Person (QCP), MMD, Customer Service and/or PhV, QP at wholesaler/distributor/importer level and/or Management (Crisis) team
• Must be hold a MS degree in pharmacy or other life science.
• An approx. minimum of 4-5 years’ experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies.
• The incumbent must be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products.
• Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.
• The incumbent should possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work.
• A mature and disciplined approach to work is essential as is the ability to coordinate the work of others.
• The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties.
• The incumbent must demonstrate proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.