Associate Director, Global Regulatory Affairs- Distributor Management
5 months ago
Description
Summary:This is an exciting opportunity for an Associate Director, Regulatory Affairs to join the Gilead Global Regulatory Affiliates & Distributor team to provide oversight and management of regulatory activities provided by Gilead´s in-market partners in the Gilead Patient Solutions (GPS) region (South Asia, South-East and Central Asia and Africa).
The role requires effective stakeholder management and collaboration with the regional leadership team, cross functional teams (Quality, Patient Safety, Trade Operations & Supply, Legal, Medical Affairs, Finance and Access), Regulatory Therapeutic Area and CMC Liaisons, and in-market partners. The main objective is to oversee all regulatory activities across the region, ensure the regulatory services provided by Gilead’s in-market partners meet Gilead’s high quality and compliance standards and are aligned with the commercial priorities. This role provides insight into the commercial & access priorities in the GPS region, the in-market business model, and provides the opportunity to develop the skills required for effective vendor oversight.
The Associate Director, GPS Distributor Management is primarily responsible for countries in Central and East Africa (Botswana, Ethiopia, Malawi, Mauritius, Mozambique, Namibia, Uganda, Zambia and Zimbabwe).
Role and Responsibilities:
Management of regulatory capability for Gilead’s in-market partners:
Due diligence
Distributor on-/off-boarding
Periodic regulatory training of the in-market partners – process and expectation setting.
Maintain oversight of legal agreements with in-market partners and understand the content of all agreements and how they impact regulatory activities.
Develop, propose, and agree regional and national regulatory strategies based on registration requirements, product knowledge and company strategy.
Maintain oversight and provide regulatory insight to optimise the regulatory strategy in relation to the product lifecycle.
Partner with the business to understand and support the commercial and access needs, align on priorities and regulatory filing strategy.
Proactively identify and support the resolution of emerging regulatory issues that may impact product supply.
Provide regulatory input to support product launch activities.
Assess and interpret regulatory intelligence and local knowledge to drive strategic recommendations.
Comment on draft regulatory guidance/legislation wherever possible in collaboration with key stakeholders.
Contribute to regional cross-functional meetings and represent Gilead Regulatory in external meetings as required.
Actively participate in Trade Associations as required.
Liaise with Gilead’s commercial manufacturing organization to plan and execute the introduction of product packaging for assigned territories in compliance with regulatory requirements.
Support Gilead in-market partner audits and Regulatory Authority inspections as required.
Core competencies
Experience in regulatory affairs across international markets, including regulatory submission experience and a good understanding of the drug development process from development through to post-marketing.
In depth knowledge of regulatory requirements, including ICH requirements and regional requirements.
Knowledge of current global and regional trends in biopharmaceutical regulatory affairs with proven effectiveness applying this knowledge.
Experience working with and / or oversight of distributor markets / external vendors is advantageous.
Ability to lead cross-functional teams, and develop, communicate and implement regulatory strategy.
Excellent verbal and written English communication skills, and demonstration of excellent interpersonal and multicultural skills.
Excellent planning and organisational skills with the ability to work simultaneously on multiple projects with tight timelines.
Demonstrated effectiveness in collaboration and teamwork, with analytical and assessment skills.
Specific Education & Experience Requirements:
Bachelor’s degree in Health or Pharmaceutical Sciences.
Significant experience in Regulatory Affairs including Pharma/Biotech industry and/or partnering with and/or responsible for oversight of in-market partners.
Experience in interacting with Regulatory Agencies.
Strong background in dossier preparation and regulatory submissions.
Ability to read, write and speak English at an advanced level.
Strong relationship building skills; demonstrated leadership coupled with the ability to work well with people at all levels and across all functions of the organization.
Advanced analytical skills.
Attention to detail and proven ability to manage multiple tasks and priorities in a matrix team environment.
Excellent communication, technical and presentation skills.
Computer skills (Advanced Microsoft Excel, Word, Outlook, and PowerPoint).
Expertise in quality systems is advantageous.
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 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.
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