Category

Description

• Oversee regulatory activities through direct reports, local consultants, partners where applicable by determining the strategy for regulatory activities, managing all stakeholders (internal and external), and executing the plan with the regulatory team

• Ensure strategic alignment with commercialization efforts and support other product activity as needed by aligning regional regulatory activities with commercial priorities in terms of interactions, new product registration submission, and maintenance activities.

• Understand regional laws, regulations, guidance, and global regulatory and political developments; develop the regulatory strategy to execute complex multi-functional filings

• Collaborate with corporate (US / EU) RA leads to communicate regional regulatory strategy for submissions, including potential risks and gating factors, to internal stakeholders located at headquarters.

• Lead/assist in the preparation of Agency meetings (meeting requests, briefing book, strategy maps).

• Perform regulatory intelligence searches and draft reports summarizing product registration and other regulatory requirements.

• Evaluate local regulations/guidances for impact to any complex submission (e.g., MA) while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards.

• Interface with external partners, contractors and some regulatory authorities as needed.

• Participate in a multi-functional team environment and help direct and implement local regulatory strategy.

• Serve as a regulatory representative on various project sub-teams and address a broad range of problems of high/moderate scope.

• Perform promotional material review for the region

• Up to 20% travel is possible

• Reports directly to the Senior Director, Regulatory Affairs International Regional Lead based in San Rafael, CA

• Expected to have 12 - 15 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the Regional Regulatory environment, especially for Turkey and Russia.

• Proven ability to independently manage critical projects as part of an interdisciplinary team. Experience managing major regulatory submissions, with the ability to successfully manage multiple projects with competing deadlines.

• Ability to work under limited direction and guidance.

• Possess a thorough understanding of relevant drug development and post-marketing regulations and guidelines.

• Must possess excellent communication skills in order to successfully liaise and influence internal/external stakeholders and communicate critical aspects of ongoing project activities. Interpersonal responsibilities will include working closely with project and other regulatory team members.

• Proficiency with computer and standard software programs is required.

• Must be fluent in Turkish and English. Other language(s) like Russian or Arabic is a plus.

Get In Touch