25 feb
Tbwa Chiat/Day
Bogotá
Contractor Senior Manager, Regulatory Affairs, LATAM
Bogota, Colombia
Why Join Us?
Be a hero for our rare disease patients
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.
To achieve this goal, our vision is to lead the future of rare disease medicine.
For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments.
We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices,
and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx.
We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work.
Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.
Position Summary:
Ultragenyx is seeking an experienced and highly motivated SR Manager, Regulatory Affairs LATAM who is a team player and thrives in a fast-paced, dynamic work environment.
The Sr 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 relevant knowledge of global rules, regulations, and guidance governing the commercialization and development of drugs and biologics in all phases.
The SR Manager, Regulatory Affairs, LATAM will be based in Bogota, Colombia.
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.
- Lead assessments of Life Cycle Management changes to provide guidance and support to global teams by applying technical knowledge, experience, and strategic solutions.
- Independently research options for regulatory strategies and present recommendations at regulatory sub-teams and to leadership.
- Manage preparation of responses to questions from health authorities in the LATAM markets.
- Lead partnerships with key stakeholders to deliver innovative strategies, facilitating interactions with local partners/consultants.
- Create and maintain submission schedules and timelines with regulatory operations and the cross-functional team, ensuring timely delivery of high-quality documents.
- Participate on 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.
Requirements:
- Pharmacy degree preferred or BA/BS degree in life sciences.
- Relevant scientific background with 6-8 years of experience in Regulatory Affairs associated roles in the biotech or pharmaceutical industries with at least three years of experience in Regulatory Affairs in the LATAM region.
- The candidate must have hands-on experience with regulatory filings in at least one of the following markets: Mexico, Colombia, Argentina, Central America, or Brazil.
- Strong knowledge and experience in interpretation of Lat
Am 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.
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
- Generous vacation time and public holidays observed by the company
- Long term incentive and Employee stock purchase plans or equivalent offerings
- Fitness reimbursement
* Benefits vary by region and country
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.
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