Contractor - Manager, Regulatory Affairs LATAM

Position Summary:

Ultragenyx is seeking an experienced and highly motivated Contractor/consultant-Manager, Regulatory Affairs LATAM who is a team player and thrives in a fast-paced, dynamic work environment. The Manager will work closely with regional and global regulatory colleagues, functional areas, and project teams to support regulatory activities in the Latin America region. The individual must possess knowledge of global rules, regulations, and guidance’s governing the commercialization and development of drugs and biologics in all phases. The Manager, Regulatory Affairs, LATAM will be based Bogota, Colombia with hybrid model requiring 3 days-office. The position will be hired with a contract through Michael Page-Colombia.

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Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

• Prepare and manage filings of regulatory marketing authorization (MA) applications in the LATAM territories, as required by the regulatory plan for the products under responsibility
• Lead assessments and execution of Life Cycle Management changes to provide guidance and support to global teams by applying technical knowledge, experience and strategic solutions
• Independently researches options for regulatory strategies and presents recommendations at regulatory sub teams and to leadership
• Manage preparation of responses to questions from health authorities in the LATAM markets
• Interface and develop partnerships with key stakeholders to deliver strategies, facilitating interactions with local partners/consultants
• Creates and maintains submission schedules and timelines with regulatory operations and the cross functional team, ensuring timely delivery of high-quality documents
• Support the LATAM regulatory team in all activities related to setting up SOPs, procedures, and databases for the department
• Participate in cross-functional committees and sub-teams in accordance with company initiatives, as necessary
• Strategic participation in trade-associations meetings as required
• Support the preparation of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages and slide deck presentations
• Support (non-)promotional material revision and approval for the LATAM markets in the system established for such activity

Requirements:

• Pharmacy degree preferred or BA/BS degree in life sciences
• Relevant scientific background with 4-6 years of experience in Regulatory Affairs associated roles in the biotech or pharmaceutical industries with at least two-years of experience in Regulatory Affairs in the LATAM region
• The candidate must have hands on experience with regulatory filings in at least two of the following markets besides Colombia: Mexico, Peru, Ecuador, Argentina, Central America or Brazil
• Relevant knowledge and experience in interpretation of LatAm regulations for MAA/LCM drug registration processes. Knowledge of foreign regulations and ICH is required
• Knowledge of orphan drug/biologics products is a plus
• Experience working with external regulatory consultants is a plus
• The desire and ability to work in a fast-paced, start-up environment, eager to learn/apply new skills
• Requires initiative, able to work independently with supervision, creative problem-solving ability, hands-on willing to work, and excellent verbal and written communication skills in Spanish and English. Portuguese is a plus
• Demonstrated ability to strategize, prioritize and manage with project management skills multiple tasks simultaneously

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Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.