Regulatory analyst

Sofia

Health Care and Pharmaceutical

Hybrid 3-5 years of professional experience 5-10 years of professional experience

Short Description

This is an entrepreneurial position within Generics: Dossiers & FDF department. You will not just handle administrative tasks; you will actively support the Business Development Team by validating dossiers, performing gap analyses, and evaluating the regulatory feasibility of potential in-licensing opportunities. Your input will directly contribute to go/no-go decisions on new global projects.

Description

Regulatory Feasibility: Evaluate potential FDF projects, initial market entry requirements, and variation pathways.
Strategic Input: Work closely with the Market Intelligence and Project Management teams to provide early-stage regulatory risk assessments.
Gap Analyses: Assist in gap analyses and prepare high-quality responses to regulatory authority questions.
Stakeholder Coordination: Coordinate document collection, clarification, and submission tracking with internal stakeholders and CDMOs.
Project Scoping: Assess country-specific requirements for target markets, identifying potential hurdles and timelines.

Requirements

Experience: Minimum 5 years of professional working experience in a business environment within the pharmaceutical sector.
Regulatory Knowledge: Strong understanding of regulatory guidelines for pharmaceutical products (experience with both EU and non-EU markets is highly preferred).
Dossier Expertise: Proven experience in performing Gap analyses and compiling regulatory submissions for FDF projects.
CDMO Interaction: Practical experience in liaising with multiple internal stakeholders and Contract Development and Manufacturing Organizations (CDMOs).
Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related scientific field.
Skills: Exceptional organizational skills, high attention to detail, and ability to thrive under tight deadlines.

Offer

Impact: A strategic role where your input is key to creating future business success.
Flat Hierarchy: Close cooperation with colleagues across the entire global organization and short, fast decision-making processes.
Compensation: Highly attractive compensation package tailored to your seniority and experience.
Global Exposure: Be part of a globally acting team.