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    Specialist - Regulatory Affairs Manager

    Merck & Co.
    5+ years
    Not Disclosed
    Bangalore
    10 Jan. 17, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Regulatory Affairs Manager, Specialist
    Location: Electronic City Phase 1, Bangalore
    Job Type: Full Time
    Experience: Minimum 5 years

    Work Your Magic with Us!

    Ready to explore, break barriers, and discover more? At our company, we’re on a mission to innovate and enrich lives in Healthcare, Life Science, and Electronics. We know you’ve got big plans – so do we! Our global team thrives on creativity, science, and technology, and we’re always seeking curious minds to help us imagine the unimaginable. Together, we dream big, care deeply, and bring lasting change to the world.

    Your Role

    As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance and license security of our products in the global markets. Your expertise will be key in preparing dossiers, executing actions that meet both company and health authority requirements, and navigating the challenges involved in licensing strategies. This position offers the opportunity to work within a matrix organization and engage with diverse stakeholders across functions, facilitating the resolution of complex tasks with close guidance from more experienced colleagues.

    Who You Are

    • Experience: Minimum 5 years of experience in the pharmaceutical environment, including 1 year in Regulatory Affairs.
    • Education: Degree in Life Science or a related field, preferably a Master’s degree (MSc).

    Key Competencies & Skills

    • Experience in preparing and managing regulatory documentation, including full international submissions and large variations.
    • Experience with lifecycle management activities across at least two regions (e.g., Europe, USA, or International).
    • Strong knowledge of post-approval changes, regulatory dossier types, and regulatory procedures globally.
    • Familiarity with the supportive documents necessary for product registration and lifecycle management (e.g., CPPs, GMP Certificates, PoAs, etc.).
    • Ability to interpret and apply country-specific and international regulatory guidelines.
    • Strong project management skills and proactive communication.
    • Experience with regulatory information management (RIM), Vault, and EDMS RA applications.
    • Excellent written and spoken English communication skills.

    Job Location

    Electronic City Phase 1, Bangalore

    What We Offer

    We are a diverse team from a wide range of backgrounds, experiences, and perspectives. We believe that diversity drives excellence and innovation, and we are committed to providing access and opportunities for growth. Join us in building a culture of inclusion that empowers everyone to champion human progress.

    Benefits

    • Financial: Generous 401(k) plan with company matching and tax-advantaged accounts for healthcare and commuting.
    • Health & Wellness: Comprehensive medical, dental, and vision coverage, including virtual care and employee assistance programs.
    • Voluntary Benefits: Discounted insurance options, personal loans, and more.
    • Work/Life Balance: Paid time off, backup daycare services, and educational assistance.

    Equal Opportunity Employer

    We are an equal opportunity employer and celebrate diversity. We are committed to creating a workplace where all individuals are treated with respect and fairness. Our policy of non-discrimination applies to all recruitment, hiring, compensation, benefits, and other aspects of employment.

    Our Recruiting Process

    1. Apply: Submit your online application for the role that fits your skills and interests.
    2. Screen: We’ll review your qualifications and determine if you're a good fit.
    3. Assess: You will be interviewed via phone, video, or in-person.
    4. Mutual Agreement: If we’re the perfect match, we’ll move forward with the offer.
    5. Onboarding: Get ready to work your magic with a smooth onboarding experience.

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    Bucharest :

    Bucharest |

    Makkah :

    King Abdullah Economic City | Najran | Rabigh | Jeddah | Khulais | Riyadh |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Peru | Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |