Senior Regulatory Affairs Specialist - dossier management

MISSION STATEMENT

Prepares, compiles and submits high quality new dossiers and regulatory applications in compliance with EU and other countries national requirements. Defines dossier content and participates on regulatory strategies definition for new in-house and in-licensing projects. Provides supervision and support to other regulatory professionals and administrative support staff. Provides regulatory support to project teams and key internal/external customers.

MAIN ACCOUNTABILITIES AND DUTIES

Preparation, compilation, review and submission of high quality regulatory applications in accordance with EU and national requirements and legislation with limited oversight.

Track and monitor queries/deficiency letters/commitments from/to Regulatory Competent Authorities to ensure these are implemented and conformed to in a timely manner.

Communicate critical regulatory information for assigned projects before, during and after approval until the point of handover to regulatory maintenance teams.

Develop and maintain a thorough and up-to-date understanding of the regulatory environment and supporting data requirements.

Align resources and discusses regulatory issues in cross-functional teams to ensure completion of project tasks.

Communicate with peers and supervisors and ensure alignment on issues, questions and goals.

Employ effective technical and regulatory writing skills to author standard regulatory documents and reports.

Preparation for and participation in meetings with internal and external stakeholders.

Provide regulatory support to project teams, stakeholders and customers, as required.

Evaluate the regulatory environment and contribute to providing internal advice and regulatory information throughout the product development and registration to ensure dossier acceptability by Competent Authorities.

Review written correspondence from peers and entry-level employees.

Provide regulatory input and appropriate follow-up for inspections and audits.

Identify the need for new regulatory procedures and SOPs, and participates in development and implementation.

REQUIRED QUALIFICATIONS & EXPERIENCE & SKILLS

Degree in biomedical sciences (Medicine/Pharmacy/Veterinary/Pharmaceutical Sciences/ Science) or Chemistry

5+ years of regulatory experience

Very good knowledge of regulatory requirements, process, procedures & pathways

Experience in registration of pharmaceutical in the EU and other countries

Knowledge of clinical development, pharmacovigilance and products life cycle management

Experience in leading projects

Very good communication skills, both verbal and written, with a passion for accuracy and attention to detail

Very good interpersonal skills – ability to effectively interact with a diverse group of people from different functions, of different nationalities and at different levels within the company

Good communication skills to transfer knowledge to entry-level employees

Good communication skills to negotiate with regulatory authorities throughout the product lifecycle

Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities

Good written and oral knowledge of English

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