Senior Regulatory Project Manager

Job Id

291154
- Lima, Lima, Peru
- Job Type

Full-time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role
- Global Regulatory Planning: Responsible for regulatory functional planning and tracking deliverables for submissions to health authorities worldwide.
- Project Plan Creation: Develops plans for initial submissions such as CTA/IND, MAA/NDA/BLA, and significant meetings with regulatory authorities.
- Strategic Collaboration: Works closely with the Global Regulatory Lead and Submission Manager to define and execute the submission strategy.
- Submission Execution: Accountable for the execution of submissions to health authorities, including the Submitter role for submissions via the CTIS portal in the EU.
- Crisis Management and Budget: Intervenes in crises impacting project timelines and consolidates budget demand as a key contact for global project management.
- Leadership and Continuous Improvement: Leads the Submission Task Force and co-chairs the International Submission Taskforce, managing regulatory activities and improving project management tools.

Who you are
- Bachelor's Degree with 5-8 years of experience OR Master’s degree with 3-6 years of experience or Ph.D wit 2-5 years of experience.
- Experience in a Regulatory environment.
- Experience in project management and technology solutions
- ln-depth knowledge and experience in own discipline and beyond

**What we offer**: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity
US Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
- Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information here.

Applicant Profile
WHAT WE OFFER
Money makes the world go round. But at our company there’s more than just financial rewards. We offer a range of attractive benefits to help you work your magic.
Saving & Finacial
Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year.
We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future.
Health & Wellness
We offer comprehensive medical, dental, & vision coverage-including virtual care through Telehealth & free behavioral health counseling sessions through our