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Job Description
Sr Manager / Associate Director Regulatory Affairs - Swiss Affiliate
Department: Regulatory Affairs Department, Gilead Sciences Switzerland Sàrl
Location: Zug, Switzerland
Reports to Director Regulatory Affairs
Job Overview
- Serves as a core member of the Swiss Affiliate Regulatory Team
- Key cross functional business partner
- Senior representative of the Regulatory function and Dev Ops at internal and external meetings
- Ensures that Gilead complies with country’s applicable legislations and regulations linked to the MA / local license as MA Holder
- Ensures that the medicinal products in his/her responsibility can be developed, authorized and maintained on the market
- Serves as a core member or leads cross functional project teams locally, regionally and globally. May also serve as a core member in global cross-functional teams
Job Responsibilities
- Provides or contributes to the Vision and Direction for the RA organization in the sub-region and / or at the country level in line with global/Regional RA and the local Affiliate Visions and sets clear goals and objectives in line with the global Dev Ops strategy
- Ensure that Gilead fulfills all relevant requirements linked to the MA / local license as MA Holder or as local legal representative of the MA Holder for the Affiliate
- Support to Crisis management functional lead and leadership team in the Affiliate
- Contributes to resource and budget planning and utilization
- Lead or support for communicating important changes to the local Regulatory and Dev Ops function/activities
- Leads the preparation of challenging regulatory submissions (initial MA Applications, line extensions, scientific advice, inspections, quality assurance related issues and risk management/minimisation activities) to local HA and leads the interaction, negotiations and communication internally and externally, coordinates cross function responses and act as the main point of contact for the local HA
- Lead or support country/national scientific advice and / or pre-submission meeting preparation and follow-up
- Accountable for managing the strict timelines associated with submission and/or variation approval.
- Ensures compliant labeling for Gilead medicinal products (SmPC, PIL, packaging) and manage timely updates for assigned product(s). Provides regulatory expertise to labelling changes and to submission teams on specified topics.
- Lead or provide Affiliate input to the International and global regulatory strategy, upon request, including input into clinical development programs
- Ensures compliance with local law and regulation and consistency with global procedural documents including Quality Assurance matters such as acting as a subject matter expert or audit / inspection lead within the affiliate, ensuring essential licenses, contracts and agreement are in place
- Initiates local improvements and contributes to local and/or global process improvements which have a significant impact for RA and other departments, assesses proposed changes to local procedural documents, sharing of best practice and impact on existing processes
- Responsible for promotional material review, submission to HA, if applicable for assigned product(s)
- Serves as a core member of the country brand/launch team or international working group as the representative of regulatory affiliate.
- Acts as a consultant to local Affiliate, regional, Intl or Global RA teams on Affiliate matters
- Takes a leadership role in conducting risk assessments on specific local regulatory issues and changes, and develops mitigation strategies as required
- A regulatory expert in updating and preparing the Company for major changes in regulatory legislation and competitor information in the country, contributes to guideline and regulation development and develops strategies to optimize the outcome
- Leads and/or is an ambassador for RA and Dev Ops at internal and external meetings or working parties building recognition as a thought leader
- Lead work in additional countries eg distributor markets as required
- Mentoring, training and coaching regulatory and non-regulatory staff
Knowledge & Skills
- Significant regulatory, quality, compliance or related experience in the biopharma industry.
- Proven track record in effectively setting and directing the regulatory or related strategy to successful conclusion for one or more products.
- Experience and proven effectiveness working and negotiating with regulatory authorities.
- Proven abilities to manage complex negotiations with regulatory authorities, as evidenced by effectiveness in negotiating with internal
- and external stakeholders in past roles.
- Proven effectiveness in making appropriate decisions independently for relatively complex projects or related issues, as evidenced by past
- decision-making track record.
- Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug
- Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix
- management responsibilities.
- Line management (direct reports) experience is strongly preferred.
- Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
Education & Experience
- 10+ years of experience in RA or other relevant industry experience with BS/BA or 8+ years of experience in RA or other relevant industry experience with advanced degree. Degree in a scientific field is preferred.
- Excellent knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements and regional requirements and have an understanding of current trends in the local affiliate.
- Must be capable of developing and implementing regulatory initiatives and of managing complex negotiations with Regulatory Authorities.
- Knowledge in quality assurance, promotional and non-promotional review as well as Pharmacovigilance and market access are advantageous.
- Excellent working knowledge regarding national/regional Regulatory Authorities essential (people, system and processes).
Languages: German preferred mother tongue, English fluent, French and/or Italian advantageous
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 individual’s 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.
Please apply via the Internal Career Opportunities portal in Workday.
