MSD Regulatory Affairs Senior Specialist 

Slovenia 

135744308

Job Description

Main Responsibilities:

• For assigned products ensures timely coordination of relevant activities, preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities in Slovenia/Albania.

• For assigned products ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications and supplemental marketing authorizations (for Slovenia and Albania).

• For assigned products ensures high quality labeling translation and artwork management.

• Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems.

• Stays updated on relevant EU and local (Slovenian and Albanian) 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. External contacts are regulatory authorities, as well as other key players in the regulatory environment.

• Ensures timely review and coordination of post approval submissions for assigned non-EU countries.

• Supports preparation of new products registrations applications for assigned non-EU countries.

• Coordinate assigned systems-related activities for assigned non-EU countries.

• Collaborate with internal and external stakeholders to support business initiatives.

Qualifications and skills:

• MS degree in pharmacy required.

• Minimum 2 years’ experience in regulatory affairs.

• Familiarity with local and EU pharmaceutical legislation and guidelines.

• Strong verbal and written communication.

• Excellent organizational and planning abilities.

• Meticulous attention to detail and flexibility in handling time pressures.

• Mature and disciplined work approach; ability to coordinate others.

• Demonstrated diplomacy and assertiveness in interactions.

• Proficient in local and English languages.

• Skilled in PC applications (word-processing, spreadsheets, databases, internet).

• Ability to work according to our company's leadership vision and maintain strong internal and external relationships.

Current Contingent Workers apply

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