Regulatory Affairs Manager (M/W/D)

Job Description

We are looking for a Regulatory Affairs Manager (m/f/d) to join our Local Regulatory Affairs team in our office in Munich. This is a permanent role.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Major Activities (may not be limited to):

• Manage and support timely and correct submission and approval of assigned New Marketing Authorization applications (MAA) and Supplemental Marketing Authorization applications (e.g. new indications, variations, renewals) in close cooperation internally with multiple departments on national, regional, and global level and close interaction with relevant regulatory authorities
• For new MAA and new major indications, design and implement local action plans to ensure proper product launch in line with local project plans
• For new MAAs and major indications manage and implement Early Access Programs (EAPs)
• Ensure timely and correct local implementation of all relevant approved Marketing Authorization applications in compliance with all applicable regulatory regulations as well as internal national, regional and global processes with regard to high quality German translation of the approved Product Information and artwork implementation and update of all relevant internal regulatory databases and archives, internal and external websites and compendia
• Support the agency interactions to ensure a seamless submission, assessment, and quick approval of the CTAs, according to the new EU CT Regulation, in cooperation with RAE Liaison, and other internal stakeholders
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed
• Participates in establishing and maintaining of relevant SOPs to secure that the current regulations are complied with
• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance

Qualification:

• Master’s degree in Pharmacy or other a relevant scientific discipline or equivalent
• Minimum of 5 years’ experience in a Regulatory Affairs Department, experience with relevant aspects of Regulatory Affairs activities, Regulatory Agency contact and experience in supervising others
• Familiar with local and EU legislation procedures and guidelines governing medicinal products and medical devices
• Experience in the translation and implementation of product information texts as well as with Market Access strategies
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to internal and external stakeholders
• Fluent in German and English
• Strong project management skills, including the ability to prioritize tasks, manage timelines, and deliver high-quality results under tight timelines
• Meticulous attention to detail, ensuring accuracy in regulatory documentation and compliance with all relevant standards and regulations
• Proficient in working in a modern digital and paperless environment utilizing MS Office tools and collaboration platforms and systems for documentation, analysis, and reporting, enhancing efficiency in regulatory processes
• Client-oriented approach and excellent relationship-building skills

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.People with severe disabilities and their equivalents will be given preference if they are equally qualified.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Requisition ID:R271828