Manager, Regulatory Affairs job Roseville Minnesota
Manager, Regulatory Affairs job Roseville Minnesota
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Manager, Regulatory Affairs Job



Employer Name: Ferring Pharmaceuticals SpiderID: 8715105
Location: Roseville, Minnesota Date Posted: 6/6/2019
Wage: Category: Management
Job Code: R0009380

Job Description:
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. Learn more at www.ferring.com and @Ferring, or connect with us on Facebook, Instagram and LinkedIn.



Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women’s health (obstetrics/gynecology), orthopedics and Oncology.  Ferring’s US operations employ approximately 900 people.
 
People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.
 
Rebiotix, a late-stage biotechnology company part of the Ferring Pharmaceutical Group, is focused on commercializing the world’s first Microbiota Restoration Therapy. By harnessing the power of the human microbiome, Rebiotix aspires to change the way challenging gastrointestinal diseases are treated. Our goal is to improve the lives of patients and reduce the cost of care associated with some of the most debilitating disorders suffered by patients worldwide. We are a passionate team of scientists, engineers and clinical researchers motivated by the opportunity to blaze new trails and create new technologies for today’s medical field, looking for like-minded individuals to add to our growing team.
 
Summary:    
 
The Manager will represent Regulatory Affairs for pharmaceutical development projects and marketed products as assigned. Working with manager, responsible for development and communication of regulatory strategy on project teams.  Working with development teams, identify and compile required documentation for regulatory submissions.  Serve as regulatory subject matter expert to advise teams.
 
Responsibilities:
 
* Ensure technical accuracy and regulatory compliance of all submissions for assigned projects and ensure that applications are executed appropriately and submitted on time.
* Compile information into regulatory documents in consultation with subject matter experts.
* Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact company products and operations. Advise personnel in other departments regarding their applicability and impact.
* Supports management with development of, and as appropriate, leads implementation of department strategies and policies. 
* Working with manager, effectively plan, organize, and participate in formal meetings with regulatory agencies as assigned. 
* Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact company products and operations. Advise personnel in other departments regarding their applicability and impact
* Supervise contractors as assigned for regulatory projects; collaborate on marketing application maintenance across multiple geographies and across business units as assigned
* Ability to work across boundaries and exercise influence without direct reporting authority


Job Requirements:
Requirements:
 
* Education equivalent to a BS degree or equivalent in a scientific field
* Advanced degree is a plus
* At least 6 years’ experience in Regulatory Affairs. 
* Analytical thinking and problem-solving skills
* Excellent communication skills, verbal and written.
* Excellent interpersonal skills and leadership potential
* Computer literate with knowledge of electronic document programs (Word, Excel, etc)
* Advanced knowledge of US and ICH regulations
* Excellent negotiation skills
* Ability to influence without direct authority
* Resilience and adaptability to a fast-paced environment

 
We are proud to be an Affirmative Action/EEO Employer.  EOE Minorities/Females/Protected Veterans/Disabled
 
We maintain a drug-free workplace and perform pre-employment substance abuse testing.

If you need assistance during the application process due to a disability, please email careers@ferring.com   
 
Location:
Minnesota


Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: Jaclyn Moore Company Type: Employer
Company:
City: Roseville
State: Minnesota
Zip:
Web Site: https://ars2.equest.com/?response_id=806754f3e3c9370108d2e364b7f5f10c

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