Regulatory Affairs Manager (m/w/d) Global Regulatory Affairs

Hiring By - Biostaffic

 BioPharma

Germany

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
YOUR CONTRIBUTION
Join our motivated team in Global Regulatory Affairs - Neurotoxins and grow with exciting challenges. As Regulatory Affairs Manager you are the key contact person for strategic and regulatory matters of our drugs including life cycle management and maintenance activities. This will include the following activities:
  • Shaping regulatory strategies and submission plans related to new registrations or life cycle management and representing regulatory requirements worldwide
  • Creating high-quality documentation and carry out required registration procedures ensuring compliance and internal requirements
  • Preparation and submission of new registrations, application files (e.g.module 1) and GMP verification as required with respect to national regulatory requirements worldwide
  • Coordinating writing documentation including response documents that are required for any regulatory submissions cross functionally
  • Regulatory implementation of change control processes and coordination of regulatory assessments, including organization of all required actions and continuous tracking and maintenance of the ECC assessment, submission and approval status and creation, updating and documentation of product information texts and packaging
  • Implementation of necessary regulatory life cycle management activities (e.g. approval or line extensions, variations, renewal, PSUR submission etc.)
  • Coordinating and supporting regulatory projects including communication with stakeholders or coordination and monitoring of third parties
  • Preparation and/or participation in scientific consultation with the regulatory authorities worldwide with the participation of internal and external functions as well as preparation
  • Contribution to regulatory intelligence initiatives, participating in regulatory agency meetings and supporting market access and Due Diligence activities
YOUR PROFILE
  • Completed scientific Studies in Pharmacy, Biology, Chemistry or a related field of studies, a doctorate is an advantage
  • At least 5 years of professional experience dealing with regulatory affairs aspects within the pharmaceutical industry
  • Very good knowledge of regulatory laws and regulations, including GMP and compliance aspects as well as CMC documents
  • Strong communication skills, also intercultural, including profound English (at least business fluent)
  • Strong problem-solving skills and analytical thinking ability
  • Team Player with performance orientation and persistence
Your Benefits
  • Individual career development in a purposeful job: you improve the quality of life of our patients!
  • Hybrid work model that allows a good work-life balance
  • Attractive location with good transport links, modern workplaces and a company restaurant (€3.80/menu)
  • Global family business with flat hierarchies and an open, respectful corporate culture
  • Attractive remuneration with extensive social benefits
  • Variety of employer-subsidized benefits such as WellPass (€17.90/month), Germany ticket (10€/month), Corporate Benefits and JobBike
About Us
Find our more about our benefits here.
Welcome to Merz Therapeutics, a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases and other health conditions regain their quality of life.
We are proud to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.
Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.
Our dedication and commitment to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.
Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal: "BETTER OUTCOMES FOR MORE PATIENTS"
For more information, visit https://www.merztherapeutics.com/.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Germany

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 15, 2024
Company Overview
Merz Therapeutics
Merz Therapeutics

Current Openings: 0

At Merz Therapeutics, we seek to address the unique needs of people who suffer from movement disorders, neurological conditions, and other health conditions that severely impact patients’ quality of life. With our patient-centric approach, cutting-edge research and development efforts, highly-scientific medical affairs resources and dedicated commercial teams, we continue the advancement of new and individualized treatment standards, including botulinum toxin. Merz Therapeutics is headquartered in Frankfurt am Main, Germany and is represented in more than 90 countries, with a North America affiliate based in Raleigh, North Carolina. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated more than 110 years to developing innovations that serve unmet patient and customer needs.
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