Director Regulatory Affairs

Gilead Sciences

Oct 14, 2024

Job
Full-time
Expert Level
Quick Apply

AI generated summary

You need a degree in Natural Sciences/Pharmacy, solid RA experience, regulatory strategy skills, people management, and excellent communication in English. Familiarity with HAs is essential.
You will manage regulatory submissions, ensure compliant labeling, advise on clinical development, liaise with health authorities, and lead a team while ensuring compliance with local regulations.

Requirements

University degree preferably in Natural Sciences or Pharmacy
Solid experience in RA or other relevant industry experience
Excellent knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements regional and local requirements and an understanding of current trends in the local affiliate
Must be capable of developing and implementing regulatory strategy and managing complex negotiations with a HA
Knowledge in quality assurance, promotional and non-promotional review as well as pharmacovigilance and market access
People management experience
Experienced leader of projects and teams
Excellent working knowledge regarding country/national and regional HAs (people, system, processes and requirements) Vision and direction setting
Leadership skills showing the ability to influence externally, cross-functionally and within RA
Extensive experience working with local HA at a senior level
Must be capable of leading project teams and working cross functional
Good decision making and prioritization skills are important
Excellent verbal and written English language skills, organization skills and interpersonal communication skills required

Responsibilities

Manages or prepares technically complex regulatory submissions to local Health Authority (HA), including initial MA application, variations, safety reports, risk minimization measures, Dear Healthcare Provider Communications, compassionate use, early access, license renewals as well as clinical trial applications and amendments, which may require extensive interaction with departments outside of Regulatory Affairs (RA)
Ensures compliant labelling for Gilead medicinal products and manage timely updates for assigned product(s)
Lead or support country/national scientific advice and / or pre-submission meeting preparation and follow-up
Provides strategic regulatory advice as appropriate including input into clinical development programmes
Support for communicating important changes to the local Regulatory and RSQ function/activities acting as a consultant to local Affiliate, regional, Intl or Global RA teams
Manages interactions, negotiations and communication with local HAs and acts as the main point of contact for the local HAs for specific topics/products under their responsibility
Helps ensure compliance with local law and regulation and consistency with global procedural documents including acting as a subject matter expert or the management of audits and inspections within the affiliate
Provides or contributes to the Vision and Direction for the RA organization at the country level in line with global/Regional RA and local Affiliate Visions and sets clear goals and objectives in line with the global RSQ strategy
Support or management of quality defects, falsified or counterfeit products, batch recalls and stock out as required
Responsible for the review of promotional and non-promotional material and approval, certifies materials where appropriate for assigned product(s)
Might act as a local Gilead representative as required by local law e.g. Qualified Person QA, QPPV, Responsible Person PV, RP QA, National qualified person for scientific service (Informationsbeauftragte)
Serve as a core Regulatory member in updating and preparing the Company for major changes in regulatory legislation and competitor information in the country for assigned product(s) or projects and contributes to guideline and regulation development
Represents Regulatory Function at internal and external meetings or working parties building recognition as a thought leader
Lead or manage work in additional countries e.g. distributor markets as required
Training or coaching of staff on key regulatory activities and updates
Ensures that Gilead complies with country’s applicable legislations and regulations linked to the Marketing Authorization (MA) / local license as MA Holder or as local legal representative of the MA Holder
Ensures that the medicinal products in her responsibility can be developed, authorized and maintained on the market
Serves as a core member or may lead cross functional project teams locally and regionally. May also serve as a core member in global cross-functional teams
Senior representative of the Regulatory function and RSQ at internal and external meetings
Manages a team of Regulatory professionals for assigned BU(s)/product(s)
As the responsible person (RP) for scientific information acc to section 74a of the German Drug law (AMG) (“Informationsbeauftragte”) ensure compliance with all regulations applicable to this position, e.g. HWG, AMG, FSA Kodex

FAQs

What is the location of the Director Regulatory Affairs position?

The position is office-based on-site in Martinsried, Munich, Germany.

Is fluency in any specific language required for this role?

Yes, fluency in German is required for this role.

What are the main responsibilities of the Director Regulatory Affairs?

The Director Regulatory Affairs is responsible for managing regulatory submissions, ensuring compliant labeling, providing strategic regulatory advice, managing interactions with local Health Authorities, and leading a team of regulatory professionals.

What qualifications are needed for this position?

A university degree, preferably in Natural Sciences or Pharmacy, along with solid experience in regulatory affairs or relevant industry experience is required.

What kind of experience is necessary for this role?

Applicants should have excellent knowledge and proven experience in understanding and implementing regulatory requirements in the Pharmaceutical/Biotech Industry, including ICH requirements, as well as experience in leading projects and managing people.

Will the Director be required to negotiate with Health Authorities?

Yes, the Director will be required to manage complex negotiations with local Health Authorities.

What is the company culture like at Gilead?

Gilead fosters a culture of collaboration, determination, and empowerment, emphasizing the importance of leadership in creating an inclusive environment for all employees.

How important is experience with local Health Authorities for this position?

Extensive experience working with local Health Authorities at a senior level is essential for this role.

Are there opportunities for training or coaching staff in this role?

Yes, the Director will be responsible for the training or coaching of staff on key regulatory activities and updates.

What type of activities will the Director be involved in with respect to promotional material?

The Director will be responsible for the review and certification of promotional and non-promotional materials for assigned products.

Gilead Sciences

Science & Healthcare

Industry

10,001+

Employees

1987

Founded Year

Mission & Purpose

The way we see it, the impossible is not impossible. It’s simply what hasn’t been achieved yet. For more than 30 years, we’ve pursued it, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving lives of people around the world. For us, nothing is impossible – because of the people we work with, the communities we stand with and the partners we push forward with. Our ~12,000 employees band together through science, grit, compassion and courage to prove the impossible wrong. At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where we start every day with one question: “What’s next?”