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    Specialist - Regulatory Affairs Manager

    Merck Kgaa
    5+ years
    Not Disclosed
    Bangalore
    10 Dec. 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Specialist, Regulatory Affairs Manager

    Location: Electronic City Phase 1, Bangalore, India

    About the Company:

    At our company, we’re driven by innovation to improve lives through our solutions in Healthcare, Life Sciences, and Electronics. Our global team is passionate about making a difference by caring for our people, customers, patients, and the planet. We’re constantly looking for curious minds ready to help us push boundaries and turn bold ideas into reality.

    Your Role:

    As a Regulatory Affairs Manager Specialist, you will play a pivotal role in preparing dossiers and executing regulatory actions to ensure product compliance and license security across various markets. You will navigate the challenges involved in aligning diverse stakeholders from major disciplines to reach consensus on licensing strategies and approaches. This role will involve working within a matrix organization, collaborating with internal and external teams to support complex tasks under guidance from experienced personnel in License Management.

    Key Responsibilities:

    • Regulatory Documentation Preparation: Prepare and manage regulatory submissions, including international new product applications and large variations.
    • Life-Cycle Management (LCM): Manage post-approval changes and lifecycle activities in at least two regions, with a focus on Europe, USA, and possibly others.
    • Regulatory Compliance: Ensure compliance with global regulatory guidelines, policies, and regulations for product registration and LCM, including necessary documentation such as GMP certificates, certificates of pharmaceutical product (CPP), and power of attorney (PoA).
    • Collaboration and Communication: Work closely with cross-functional teams to ensure smooth communication, meeting deadlines, and proactively addressing potential risks.
    • Regulatory Strategy: Support the licensing strategy and assist in managing product compliance according to health authority requirements.

    Who You Are:

    • Experience:
      • Minimum of 5 years of work experience in the pharmaceutical industry, competent authority, or academia/R&D.
      • At least 1 year of regulatory affairs experience, specifically in regulatory documentation and submissions.
    • Education:
      • Degree in Life Sciences or related discipline (preferably MSc or equivalent).
    • Key Competencies & Skills:
      • Strong experience in regulatory documentation management, including international submissions and variations.
      • Familiarity with life-cycle management activities in at least two regions (e.g., Europe, USA).
      • Understanding of regulatory dossier types, post-approval changes, and regulatory procedures globally.
      • Ability to interpret and apply international and country-specific regulatory guidelines.
      • Strong project management and documentation skills with proactive communication.
      • Experience with RIM, Vault, and EDMS RA applications.
      • Excellent written and spoken English.

    Job Location:

    • Electronic City Phase 1, Bangalore, India

    We Are an Equal Opportunity Employer:

    We value diversity and are committed to a non-discriminatory policy. We encourage applications from all backgrounds and believe that inclusion fosters innovation and drives excellence. We are dedicated to providing opportunities for personal and professional growth.

    What We Offer:

    We are committed to creating an environment where everyone can thrive. We celebrate diversity in all forms and believe it is essential for excellence. We offer opportunities to develop and grow at your own pace, and join a culture of inclusion that impacts millions and empowers everyone to work their magic.

    Apply Now:

    If you’re ready to make a difference and contribute to a high-impact team, apply now and become a part of our diverse workforce!

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    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |