Regulatory Affairs Manager

Job Description

Regulatory Affairs Manager Turkiye; is responsible from managing RA submissions & supporting Clinical Trials applications and will serve as a core member of the affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with country’s applicable legislations.

Knowledge & Details:

• Manage regulatory submissions to local HA submissions inc. but not limited to Pre-MAA related activities (GMP & prioritization applications), marketing Authorisation (MA) applications & variations and other MA maintenance applications, in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects.

• Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.

• Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.

• Manage clinical trial applications, amendments, and notifications. Collaborate with Clinical Operations and the CT Hub to complete CT submissions to MOH timely and interacts with cross-functional teams internally and externally to ensure submission package fulfils the MoH requirements on time.

• Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.

• Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.

• Ensure good and strong relationships with functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc.) and with Gilead Sciences Global/Regional RA in order to ensure the success of local and international business results from the regulatory point of view.

• Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.

• Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.

• Actively contribute to local and global initiatives that improve regulatory processes.

Professional Experience / Key Skills

• Solid experience in total in Regulatory Affairs & Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.

• Degree in Pharmaceutical Sciences or equivalent discipline is preferred.

• Proven ability to prioritize, conduct, and manage time to meet project deadlines.

• Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.

• Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.

• Strong focus on achievement of goals and continuous improvement

• Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.

• Having excellence in multiple project management, good communication and interpersonal skills.

• Be an analytical thinker, problem solver, proactive, initiative taker, creative personality

• Team player who actively contributes to the team in order to complete tasks, meet goals or manage projects, actively listen others, respect ideas and aim to improve the process.

• Fluency in spoken and written English.

• Good decision-making skills are important.

• Excellent verbal, written, organization skills and interpersonal communication skills required.