Regional Regulatory Affairs Manager (m/f/d) APACMEA
Merz Therapeutics GmbH, Welcome, SC, United States
YOUR CONTRIBUTION
As a Regional Regulatory Affairs Manager (m/f/d), you will provide regional regulatory support for the strategic development, approval, and life cycle management of drugs, ensuring compliance with regulatory and legal requirements in the region APACMEA. This will include the following activities:
Dossier Preparation: Develop and maintain high-quality regulatory documentation for APACMEA region, ensuring compliance with internal and international standards
Marketing Authorization: Coordinate and submit applications for new registrations, approvals, and GMP verifications, adhering to national regulatory requirements
Change Control & Product Information: Implement local regulatory changes and update product information texts and packaging in line with company and national standards
Life-Cycle Management: Manage regulatory life-cycle activities, including renewals, variations, and post-approval commitments, in collaboration with internal and local teams
Response Management: Handle deficiency letters from regulatory authorities, ensuring timely and accurate responses
Project Coordination: Communicate regional regulatory needs to global teams, coordinate with local partners, and manage third‑party service providers
Regulatory Strategy & Intelligence: Contribute to regulatory strategies and stay updated on regional regulatory requirements and best practices
Agency Interactions: Prepare for and participate in meetings with regulatory authorities, collaborating with local and global stakeholders
YOUR PROFILE
Completed scientific studies in Pharmacy, Biology, Chemistry or a related field of studies; a doctorate is an advantage
3-5 years of professional experience dealing with regulatory affairs aspects in the region APACMEA and specifically the centralized procedure within the pharmaceutical industry
Strong communication skills, also intercultural, including profound English (at least business fluent)
Strong problem‑solving skills and analytical thinking ability
Team player with 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
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, Deutschland‑Ticket, Corporate Benefits and JobBike
Find more about our benefits here.
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As a Regional Regulatory Affairs Manager (m/f/d), you will provide regional regulatory support for the strategic development, approval, and life cycle management of drugs, ensuring compliance with regulatory and legal requirements in the region APACMEA. This will include the following activities:
Dossier Preparation: Develop and maintain high-quality regulatory documentation for APACMEA region, ensuring compliance with internal and international standards
Marketing Authorization: Coordinate and submit applications for new registrations, approvals, and GMP verifications, adhering to national regulatory requirements
Change Control & Product Information: Implement local regulatory changes and update product information texts and packaging in line with company and national standards
Life-Cycle Management: Manage regulatory life-cycle activities, including renewals, variations, and post-approval commitments, in collaboration with internal and local teams
Response Management: Handle deficiency letters from regulatory authorities, ensuring timely and accurate responses
Project Coordination: Communicate regional regulatory needs to global teams, coordinate with local partners, and manage third‑party service providers
Regulatory Strategy & Intelligence: Contribute to regulatory strategies and stay updated on regional regulatory requirements and best practices
Agency Interactions: Prepare for and participate in meetings with regulatory authorities, collaborating with local and global stakeholders
YOUR PROFILE
Completed scientific studies in Pharmacy, Biology, Chemistry or a related field of studies; a doctorate is an advantage
3-5 years of professional experience dealing with regulatory affairs aspects in the region APACMEA and specifically the centralized procedure within the pharmaceutical industry
Strong communication skills, also intercultural, including profound English (at least business fluent)
Strong problem‑solving skills and analytical thinking ability
Team player with 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
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, Deutschland‑Ticket, Corporate Benefits and JobBike
Find more about our benefits here.
#J-18808-Ljbffr