Regulatory Affairs Manager at Gilead Sciences

Istanbul, Istanbul, Turkiye

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Solid experience 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

Responsibilities

Manage regulatory submissions to local HA including 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
Ensure 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

Skills

Regulatory Submissions

Marketing Authorisation

Clinical Trials Applications

GMP

ICH Guidelines

Regulatory Affairs

HA Interactions

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

Land your dream remote job 3x faster with AI

Try Jobo Free