MSD Senior Specialist Regulatory Affairs 

Finland, Espoo 

826518885

Job Description

As the Senior Specialist, Regulatory Affairs, your role is to

• Ensure timely preparation, submission and appropriate follow-up of new Marketing Authorization applications at local level in collaboration with Regulatory Affairs Europe.
• Manage maintenance of authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• Ensure timely, accurate and compliant labelling translations and artwork preparation.
• Stay updated on our company’s late pipeline filings, relevant EU and local regulations and guidelines, and develop and maintain positive relationship with key regulatory stakeholders.
• Work alongside the business units locally to support business initiatives and projects in Finland.
• Maintain positive relationship with internal and external regulatory contacts on sub-regional and regional levels and collaborate with colleagues from other departments such as Medical Affairs, Quality, Pharmacovigilance, Logistics, Market Access, Policy and Business units. External contacts include regulatory authorities, as well as other key players in the regulatory environment.

Major Activities:

• Support preparation, submission and approval of assigned new Marketing Authorization applications in close cooperation with Regulatory Affairs Europe, Medical Affairs, Quality, Market Access, Policy and Business units, as well as with local regulatory authorities as appropriate.
• Ensures that marketing authorizations are maintained in compliance through performing the necessary activities, including variations and renewals, within the agreed timeframes and communicates approvals to stakeholders.
• Ensures timely preparation, maintenance and high-quality translations of local Summary of Product Characteristics, Package Leaflets, additional risk minimization materials, preparing artworks and other applicable regulatory documents according to our company’s and local standards.
• Implement Prescribing Information within the correct timeframes.
• Ensures that all internal stakeholders receive relevant information regarding the regulatory status of the assigned products.
• Ensures efficient implementation and use of internal and external regulatory databases and systems.
• Obtain early information about new studies to be able to support local Clinical Trial Applications as well as negotiate with local regulatory authorities as appropriate.
• Ensures adequate support to other functions to enable compliance in areas related to regulatory and secures timely and adequate information and decision-making about regulatory issues in cross-functional teams.
• Take part in product and launch teams to provide regulatory input and strategy advice.
• Shape the regulatory environment by liaising with the local agency, local pharmaceutical organization and other stakeholders, in concurrence with the EU Regulatory Policy.

Skills Required:

• Master’s degree in pharmacy or a related life science field
• A minimum of 4 years’ experience in regulatory affairs, including direct interactions with regulatory agencies.
• Proficiency in Finnish, Swedish, and English
• Strong verbal and written communication skills
• Exceptional organizational and planning abilities
• Meticulous attention to detail
• Ability to handle conflicting time pressures and a high volume of work
• Ability to demonstrate diplomacy and assertive skills in dealing with internal and external parties
• Proficiency in PC applications, including word processing, spreadsheets, database usage, and internet

Current Contingent Workers apply

No Travel Required

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.

Job Posting End Date:10/01/2024

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.