Nordic Head Regulatory Affairs

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Job Description

NORDIC HEAD REGULATORY AFFAIRS

Responsible for working with local Nordic Regulatory Authorities (Denmark Finland Iceland Norway Sweden) and other stakeholders to ensure that the company complies with countrys/ies applicable legislations and regulations pertaining to our portfolio (at all stages of the products life cycle) i.e. ensure that Gilead medicinal products can be

• developed

• authorized

• maintained on the market

1. Essential Duties and Responsibilities

1.1. Core Technical Regulatory Contributions

Interaction with Local Health Authorities (HA)

Lead the interaction and communication with the local HAs and act as the main point of contact for the local HAs This includes (not exhaustive):

Works proactively to build and maintain contacts with relevant local HA personnel.

Lead interactions with other departments/functions for response to local HAs.

National Scientific Advice and pre-submission meeting preparation and follow-up.

Management of relevant local HA inspections.

Quality defects / falsified or counterfeit products / batch recall management.

Out of stock situation management.

Management of or support for incidents involving regulatory matters (as required).

Dear Healthcare Provider Communications submissions and follow-up until approval.

Risk Minimization Measures submissions and follow-up until approval.

Regulatory Submissions

Ensure that all regulatory submissions to local HAs are done in line with local HA expectations Gilead SOPs and business objectives for assigned product(s) and country.

Main types of submissions are (not-exhaustive):

Clinical trials applications amendments and other clinical trials submissions.

Compassionate Use & Early Access applications.

Marketing Authorisation (MA) applications.

Variations and other MA maintenance applications.

Import permits.

Risk Minimization Activities materials.

Dear Health Care Professional communication.

Promotional materials.

Local Statutory Responsibilities and Liabilities

Ensure that Gilead fulfills all requirements linked to the Marketing Authorization/ local license as Marketing Authorization Holder or as local representative of the Marketing Authorization Holder.

Act as the local Gilead representative as required by national law.

Compliance with the Relevant Laws and Regulations that Relate to the Core Activities of Regulatory Affairs in Gilead

Ensure compliance with local law and regulation and consistency with global procedural documents.

Lead the creation maintenance training evaluation and tracking of all local regulatory owned procedural documents including policies SOPs manuals and working instructions that are needed locally to fulfill regulatory obligations including but not limited to those in the scope of GMP/GDP GPvP and GCP.

Manage Regulatory Compliance audit within affiliate and assure that the General Manager and other departments are aware and support the process.

Maintain GDP license in the country as required and set up internal and 3PL audits management as appropriate.

Ensure the establishment of Quality Agreement where required with 3PL.

Promotional material review and approval submission to HA if applicable.

Ensure compliant labeling for Gilead medicinal products in the country (SmPC PIL packaging) and manage timely updates.

Local Coordinator GDocs / GxPLearn.

Input into Development

Provide input to the global regulatory product strategy upon request.

Share with International Regulatory Affairs (Int RA)/development teams knowledge on:

• HA expertise expectations and requirements.

• National scientific advice relevance and requirements.

• Regulatory Authority contact profiling.

Manage negotiations with local HAs with regards to development products eg questions on clinical trial applications.

Regulatory Intelligence

Closely monitor and report all external relevant changes to concerned stakeholders within the company at local and global level. That applies for local requirements to be explained at the local and International level but also for changes or new information at International level affecting affiliates.

Monitor competitor regulatory information such as approvals changes in label and other relevant local details. If applicable Regulatory Affairs (RA) contributes to relevant local guidelines and regulations development that impact Gilead identifying trends and changes that may impact on the company.

Anticipates potential challenges in registration and changes in health care policies that could impact Gilead and develop strategies to optimize the outcome.

Maintains up to date knowledge of highly complex regulatory requirements contributes to preparation of new local regulatory guidance when applicable comments on draft regulatory guidance and communicates changes in regulatory information to Int RA.

Participates in industry trade groups and regulatory affairs professional societies.

1.2. Non Core (but critical) Technical Regulatory work

Pharmacovigilance (PV): Oversight of the PV activities in the Nordics and partners with the local PV group on regulatory matters

Market Access (MA): Partners with the MA group on regulatory matters

Business Conduct (BC): Partners with the BC group on regulatory matters

Medical Information MI: Partners with the MI group on regulatory matters

1.3. Management and Leadership

Provide the Vision and Direction for the RA organization at the country level in line with global RA and the local Affiliate Visions.

Serves as a core member of the country leadership team as the representative of R&D.

Leads the country regulatory team and serves as a core member on the International Regulatory Heads fora.

Sets clear goals and objectives in line with the global RA strategy.

Actively participates in internal and external working groups.

Leads and / or represent RA within cross-functional and/or cross-regional regulatory sub-teams.

Plan monitor allocate and optimize resources and budget with regards to portfolio evolution as well as regulatory changes.

Ensure a sufficiently staffed and adequately trained RA department.

Develop local RA team with clear succession plans for critical roles.

2. Key Differentiating Responsibilities / Contributions

Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory

Ensure optimum execution of Int RA registration strategies and plans with multiple functional areas in the country.

Establishes and maintains good and strong relationships with all functional areas of the local organization (Medical Affairs Commercial Market Access Legal etc) and with Gilead Sciences Int RA in order to ensure the success of local and international business results from the regulatory point of view

Takes a leadership role in conducting risk assessments on major local regulatory issues.

Take the leadership role in updating and preparing the Company for major changes in regulatory legislation in the country

Decision Making: Makes important decisions that impact the department and ensure appropriate communication

Plays an active role in industry organizations building recognition as a thought leader as required locally if appropriate.

Initiates or contributes to local and / or global process improvements which have a significant impact on Gilead.

Represents Regulatory Function at internal meetings

Specific Education & Experience Requirements:

• 12 years of experience in Regulatory Affairs or other relevant industry experience
• Degree in a scientific field is preferred
• Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements regional requirements and scientific and company policies and procedures.
• Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance is met for assigned product(s) and territories.
• Prepare and/or manage others submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
• Responsible for submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories.
• Responsible for ensuring preparation of the Product Company Core Data Sheets (CCDS) regulatory review of draft Product Company Core Safety Information (CCSI) and ensuring that any updates to the CCDS or CCSI are implemented in a timely manner.
• Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license. Acts as project team representative and may act as submission team representative for specified products.
• Represents Regulatory Function at internal meetings. Works proactively to build contacts with local Regulatory Authorities. Participates in industry trade groups and regulatory affairs professional societies.
• Maintains knowledge of highly complex regulatory requirements up to date contribute to preparation of new regulatory guidance wherever possible comments on draft regulatory guidance and communicates changes in regulatory information to project teams and senior management.
• Initiates or contributes to local and / or global process improvements which have a significant impact on the business.
• Excellent verbal written negotiation and interpersonal communication skills are required. Ideally fluent in a local Nordic language
• Must have an extensive knowledge of regulatory requirements including ICH requirements and regional requirements for assigned territories and have an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business.
• Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
• Excellent influencing and negotiation skills.
• Must be capable of taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories which impact many departments.
• Must be capable of leading one or more teams in preparation of submissions and maintenance of licenses.
• Work is performed under consultative direction towards corporate regulatory goals and objectives.
• Schedules and arranges own activities and those of direct report(s) (if applicable).
• Is recognized as an expert resource for Regulatory Advice in other departments.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.