Regulatory Affairs Supervisor M/F (30179)

 

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

 

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

 

Achieve, Cooperate, Care and Innovate are the values ​​that we share and practice on a daily basis.

 

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

 

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

 

I-Common missions for this position

 

General Management

• Implements locally the Group RA policy, strategy and objectives as defined by the Head of Global Regulatory Affairs
• Manage the tasks for regulatory affairs, pharmacovigilance, promotional material review on regulatory perspective and support the quality assurance matters.
• To give quarterly feedbacks & updates about Policies related to DCGI / CDSCO and other regulatory authorities in India & other territories.

 

Regulatory (geographical perimeter = India, Srilanka, Nepal, Bangladesh)

• Drive drug & medical device registrations and variations in accordance with relevant regulations and develop the strategy to obtain the product approval within target timeframe
• Register and keep maintenance of production sites abroad.
• Keep abreast of regulatory procedure and product changes to ensure products documents are maintained in compliance with local and corporate instruction.
• Effectively communicate and collaborate with Regional / Corporate RA and Pharmaceuticals team in order to develop Regulatory Strategies & to provide local regulation intelligence to internal stakeholders
• Maintenance of registration data base locally.
• Maintain contact with the DCGI & CDSCO regulatory authorities & make regular official visits their offices to keep updated on the latest happenings.
• Work along with the local Regulatory liaison agent for smooth execution & handover process.
• Support the Regulatory prices related subjects in collaboration with commercial.

 

Vigilance

• Be responsible for Pharmacovigilance including reporting / communication with HQ and authorities.
• Implement Corporate SOPs, maintain local PV and MDV system and update local SOPs
• Being a role of LRPPV (local responsible person of pharmacovigilance) and LRPMV (local responsible person of Meteriovigilance)
• Ensure all PV and MDV related submissions are made & updated on time, in coordination with the HQ Team, Regional Team and in-country team.
• Work along with the Deputy LRPPV and LRPMV. 

 

Quality Management

• Support the Implementation of corporate SOPs & local SOPs development on GxP,GDP and GDP certification & maintenance.
• Handle quality related questions and complaints
  
  

Compliance and Administrative Duties

• Ensure company’s products comply with the regulations
• Plan and coordinate pack changes with related department
• Validation of promotional material and packaging materials in compliant with local regulation and corporate policy

 

Educations & Experiences

• Pharmacist or related academic background is preferred
• 8 years of relevant experience in pharmaceutical drug registration.
• Experience in medical device registration, quality assurance or pharmacovigilance is favorable.

 

Skills & Qualifications

• A good working knowledge of legal and regulatory issues
• Proficient in MS Office, including Word, Excel and PowerPoint
• Effective communication and interpersonal skills
• Detail-oriented and independent team player
• Excellent verbal and written communication skills in English and Hindi.
• Work precisely according to procedures, rules and regulations
• Recognize recurring issues and analyze their causes in order to reach a solution

 

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, 
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

 

We # Innovate # Cooperate # Care #Achieve at Guerbet. 

 

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

 

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717