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Biogen
Biogen
5001 – 10.000 Zaposleni
Sponzor vizuma H1BBiotehnologijaProizvodnjaZdravstveno varstvo
Biogen je biotehnološko in zdravstveno podjetje, osredotočeno na raziskovanje, razvoj in zagotavljanje zdravljenj za resne nevrološke bolezni. Njegovo delo zajema bolezni, kot so Alzheimerjeva bolezen, multipla skleroza in spinalna mišična atrofija, pri čemer združuje klinične raziskave, znanstveno sodelovanje in razvoj zdravil za napredek nevrologije. Podjetje poudarja tudi izboljšanje dostopa do zdravstvene oskrbe ter spodbujanje večje enakosti v zdravstvu.
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Delovna mesta v podjetju

Senior Manager, Global Regulatory Affairs at Biogen

Support regulatory strategy and submissions for Biogen’s biotechnology programs, including IND, CTA, NDA, and BLA filings. Coordinate health authority responses, labeling, and submission execution with global and cross-functional teams.

USZdružene države AmerikeCAKalifornija
140.000 $ – 187.250 $ / leto
HibridnoPolni delovni časSeniorZahtevani Jezik: angleščinaSkladnost
Vault

Opis

  • Partner with the Global Regulatory Lead on strategy and execution for assigned programs.
  • Contribute regulatory input to cross-functional teams and align submission plans with labeling strategy.
  • Lead or support reviews of IND, CTA, NDA, BLA, and supplemental submission packages.
  • Manage health authority inquiries and deliver timely, accurate responses through resolution.
  • Coordinate submission logistics and document delivery with Regulatory Operations and CROs.
  • Advise on US labeling precedence and help implement US labeling across functions.
  • Update regulatory systems such as GRIT to track submission approvals related to supply release.
  • Provide backup coverage for regulatory colleagues to maintain continuity of support.

Zahteve

  • Bachelor’s degree and at least five years of regulatory affairs experience in the pharmaceutical or biotechnology industry.
  • Strong grasp of global regulatory requirements, including the ability to interpret regulations, guidelines, and policy statements.
  • Experience managing regulatory submissions across regions and formats, including INDs, CTAs, and NDAs or BLAs.
  • Strong planning, organization, and project management capabilities.
  • Clear written and verbal communication skills for explaining regulatory topics and updates to cross-functional teams.
  • Ability to build effective cross-functional relationships and contribute to creative problem-solving.
  • Experience with regulatory platforms and tools such as Veeva Vault, Docubridge, and CTIS.
  • Able to work independently and reliably in a fast-paced, matrixed team environment.

Ugodnosti

  • Eligible regular employees may receive short- and long-term incentives, including cash bonuses and equity awards.
  • Medical, dental, vision, and life insurance coverage.
  • Fitness and wellness programs, including fitness reimbursement.
  • Short- and long-term disability insurance.
  • At least 15 days of paid vacation, plus year-end shutdown leave from December 26 through December 31.
  • Up to 12 company-paid holidays and three paid days off for Personal Significance.
  • 80 hours of sick leave per calendar year.
  • Paid maternity and parental leave.
  • 401(k) plan with company matching contributions.
  • Employee stock purchase plan.
  • Tuition reimbursement up to $10,000 per calendar year.
  • Access to employee resource groups.

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