Head of Regulatory Affairs Colombia
Colombia - Bogota
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
We are looking for a unique individual who is passionate about advancing therapeutics and with creative problem-solving skills to seamlessly meet the business needs while maintaining regulatory compliance. This is an exciting opportunity for an experienced regulatory professional to head the newly created Regulatory Affairs position based in Colombia. This position will report to the Regulatory Affairs Executive Director for the Intercontinental region. The head of Regulatory Affairs Colombia will be responsible for establishing Regulatory Affairs within the newly created affiliate. The individual will be accountable for the regulatory strategy and execution of all therapy programs including NDA and life cycle submissions whilst ensuring compliance with applicable laws, policies and operating procedures in country. The role involves close cross-functional collaboration with a diverse number of stakeholders both internally and externally.
The head of Regulatory Affairs will be a member of the Country Leadership team.
The responsibilities for this role include, but are not limited to:
- Accountable for collaborating cross-functionally to ensure the development and execution of robust regulatory strategies whilst ensuring regulatory compliance
- Ensure project team colleagues, line management, and key stakeholders are appraised of developments that may impact regulatory success, exercising sound judgement and communicating in a timely manner
- Responsible for anticipating and quantifying risks and proposing solutions with the probability of success.
- Accountable for regulatory submissions and approvals, in collaboration with internal and external stakeholders
- Serve as the direct point of contact with health authorities, leading and managing health authority interactions/meetings
- Accountable for establishing strong working relationships with the regulatory central team, other functions as required and the distributor as necessary to ensure global regulatory submissions are provided to local representative in compliance with local regulations and to maintain compliance
- Participate in or lead departmental and cross-functional taskforces and initiatives
- Actively monitor and anticipate trends that impact both the regulatory and access environment and adapt regulatory strategies in a timely manner
- Provision of guidance to key stakeholders during the preparation of promotional materials & activities; review and approve promotional materials in accordance with national legislation and Codes of Practice and company policies and procedures.
- Responsible for ensuring responsibilities of applicant and/or License Holder defined in legislation and regulatory guidance are met for assigned product(s).
- Oversees preparation and maintenance of country specific labeling and product packaging ensuring alignment with applicable guidelines.
- Obtain and maintain necessary regulatory-associated licenses and obligations with National Regulatory Authority in order to enable Gilead to conduct its business.
- Establishment of good working relationships with National Regulatory Agencies.
- Participation in agreed industry working groups.
- Coordination and preparation for local internal audits and local authority inspections.
- Preparation and maintenance of SOPs and associated process documentation as required of regulatory affairs, both internally and externally.
Competencies / Skills / Knowledge
- Review and approval of packaging materials in line with approved licenses and Gilead's internal processes.
- Managing product complaints, as needed
Education & Experience:
- Strong influencing and negotiating skills. Must be capable of developing and implementing regulatory strategies and of managing complex negotiations with Regulatory Authorities.
- Strong leadership skills with a sphere of influence externally, cross functionally and within the RA function and the affiliate.
- Direct experience working with Regulatory Authorities is essential.
- Data driven in decision making with the ability to analyse complex situations, focus on the key issues and communicate with clarity.
- Excellent verbal, written, organization skills and interpersonal communication skills.
- Team player with the ability to navigate cross-functionally in matrix organizations.
- Degree in a relevant scientific discipline, an advanced degree is desirable.
- Extensive relevant experience in regulatory affairs in the Biotech/Pharmaceutical industry.
- Strong knowledge of federal local health law
- Fluent in spoken and written Spanish and English is mandatory.
For Current Gilead Employees and Contractors:
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