MSD Regulatory Affairs Specialist 

Latvia, Vidzeme, Riga 

484430457

Job Description

Position Overview:

• For assigned products and under supervision of Baltic Regulatory Affairs Lead ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization (MA) applications to the local authorities and – as applicable – to the EMA.
• For assigned products and under supervision of Baltic Regulatory Affairs Lead ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications and supplemental marketing authorizations.
• For assigned products ensures high quality labeling translation and artwork management.
• For assigned products and tasks stays updated on relevant EU and local regulations and guidelines.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
• Maintains a positive relationship with internal and external regulatory contacts. Global Regulatory Affairs & Clinical Safety (GRACS) on sub-regional, regional and global level, our Manufacturing Division and EUPV are the main contact points within the company. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
• By discretion of Regulatory Affairs management and due to organization and workload, all listed activities need not to be performed.

New MA applications for assigned products:

• Under supervision, performs timely and correct submissions and approvals of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing, external affairs departments, our Manufacturing Division, GRACS on sub-regional, regional and global level, as well as with local regulatory authorities as appropriate, depending on procedure type. Tracks process on products registration and major new indications.

Maintenance of licenses for assigned products:

• Under supervision, ensures that Marketing Authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicate approvals to stakeholders through the correct processes.

Compliance:

• For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, packaging material and other applicable regulatory documents according to our company and local standards and relevant Artwork Management procedures. Implement prescribing information within the correct timeframes for compliance.
• Ensures that all internal customers receive relevant information with regard to the regulatory status of the assigned products.
• Ensures the correct and proper utilization of Artwork Management System to generate products´ mockup artwork and to implement revisions to artwork.
• 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 Affairs are kept updated and complete.
• Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
• Participates in implementation of updated regulatory documentation according to regulatory authority requirements and in-house guidance.

Editing and labeling:

• In connection with submission of MA applications, variations and renewals etc., provides translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and ensures quality assurance including linguistic check of these documents.
• The above-mentioned tasks are performed under supervision of Baltic Regulatory Affairs Lead as well as Regulatory Affairs International, Worldwide Product Labeling, Regulatory Affairs Europe, and our Manufacturing Division in Europe.

Artwork:

• Prepares artwork, including package leaflets and all other components in a timely and correct manner and according to relevant Artwork Management procedures.
• The incumbent ensures proof reading of packaging components and is responsible for maintaining an updated file on packaging components, as applicable.
• Cross-functional activities, as assigned
• Secures timely and adequate information and decision making regarding regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
• Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.
• Adequately supports other functions to enable compliance in areas related to regulatory, such as PSUR submissions.

Regulatory environment:

• Keeps abreast of local and international laws.
• Shapes the regulatory environment through liaising with the local regulatory authority, local pharmaceutical organization and other stakeholders, and in concurrence with the EU Regulatory Policy lead.
• Participates in internal European regulatory workgroups on selected issues.

Skills Required:

• Must be at least B.Sc. in pharmacy or life science.
• A minimum of 2 years’ experience in the pharmaceutical industry is preferable, in a regulatory, medical or laboratory position.
• 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.
• Must be able to work both alone and as part of a team and have the ability to concentrate on large volumes of written/paper-based work in an office environment. The incumbent must demonstrate full proficiency in Latvian and English language as well as PC use with regard to word-processing, spreadsheets, database application and internet.

Current Contingent Workers apply

Not Indicated

*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.