Внимание! Вакансии нет на российских job ресурсах.
А science-led, patient-centered biopharmaceutical company PTC Therapeutics is looking for an Associate Director — Regulatory Affairs (Russia CIS).
Responsibilities of the role include:
In alignment with PTC’s global regulatory strategies, assists in the development and implementation of regional regulatory strategies for PTC compounds in all stages of clinical and commercial development. Is integral in the preparation of regulatory dossiers in Russia and CIS to align with and enable business strategy in the region.
Serves as a liaison to regional regulatory Health Authorities in Russia, Kazakhstan, and Belarus and provides guidance and advice on regulatory and policy developments to PTC’s global regulatory team and other key stakeholders. Actively maintains knowledge of regulatory requirements (e.g. new regulations, laws, etc.) and shares key insights with the business and global team.
Supports strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions including, but not limited to Clinical Trial Applications (CTAs); Marketing Authorization Approvals (MAAs) including those required to maintain approvals (i.e. variations, renewals, labeling) and customized dossiers for the registration of drug products in countries within the region.
Provides regulatory support for country-specific Early Access Programs (EAPs). This may also include the preparation of supportive regulatory documents for these programs.
Collaborates with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations.
Ensures that drug products distributed with the region meet local regulatory requirements while also supporting PTC’s commercial/business objectives, including review of media, promotional material
Provides regulatory support to the Global Pharmacovigilance (PV) organization as necessary to ensure that PTC’s PV obligations are met.
Contributes to the organizational design of the regulatory affairs function and contributes to the selection of resources required to meet departmental and corporate objectives. Supports the coordination of contracted activities for translation, submission of regulatory documentation, and contact with local Health Authorities.
Performs other tasks and assignments as needed and specified by management.
Requirements For The Role Include
Bachelor’s degree in a relevant discipline and a minimum of 7 years of progressively responsible Regulatory Affairs experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment with at least 2 years of successful experience in a regional Regulatory Affairs role.
Prior experience helping to build a regional Regulatory Affairs function for a growing organization is beneficial.
Experience working with rare and orphan diseases
In-depth knowledge of relevant, regional regulatory guidelines and requirements.
Demonstrated, hands-on experience managing and preparing all phases of regional/country-specific regulatory submissions including knowledge of National, Mutual Recognition, and Decentralized/Centralized procedures.
Demonstrated track record of success building relationships with, and influencing, regional and/or national health authorities, particularly in situations requiring direct interaction/negotiation.
Demonstrated success in gaining regional regulatory approval and in providing regulatory support for post-marketing and life cycle management activities such as variations, renewals, and labeling.
Demonstrated hand’s on experience interacting with regulatory authorities
Experienced providing regulatory support for CTAs and Chemistry, Manufacturing and Control (CMC) related activities, Quality Assurance, PV, Supply Chain, and Compliance.
Strong interpersonal skills to manage efficiently relationships with Health Authorities
Ability to influence
Excellent verbal and written communication skills
Ability to work independently and collaboratively
Fluent in Russian and English (verbal and written).
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