Instagram
youtube
Facebook

Specialist - Regulatory Affairs Manager

5+ years
Not Disclosed
10 Feb. 11, 2025
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

Rewritten Job Description: Specialist - Regulatory Affairs Manager

 

Position: Specialist - Regulatory Affairs Manager

📍 Location: Electronic City Phase 1, Bangalore, Karnataka, India
📅 Job ID: 279902
👨‍💼 Job Type: Full-time

Work Your Magic with Us!

Are you ready to explore, innovate, and break barriers? We are a global leader in Healthcare, Life Science, and Electronics, dedicated to transforming lives through cutting-edge solutions. We value curious minds and passionate individuals who are eager to imagine the unimaginable with us.

Your Role:

As a Specialist - Regulatory Affairs Manager, you will be responsible for preparing regulatory dossiers and ensuring license security and product compliance in global markets. You will navigate complex license management strategies, collaborating with cross-functional teams to achieve compliance with company and health authority regulations.

💡 Key Responsibilities:

  • Prepare and manage regulatory documentation for international submissions and product variations.
  • Handle life-cycle management (LCM) activities across multiple regions (e.g., Europe, USA).
  • Interpret and apply global regulatory guidelines, policies, and procedures.
  • Ensure compliance with post-approval changes and regulatory dossier requirements.
  • Work with supportive regulatory documents (CPPs, GMP Certificates, MLs, AtO’s, AFs, CLs, PoA’s, etc.).
  • Adhere to regulatory timelines while proactively managing risks.
  • Utilize Regulatory Information Management (RIM), Vault, and EDMS RA applications.
  • Collaborate with internal teams in a matrix organization to streamline regulatory processes.

Who You Are:

✔️ Experience:

  • 5+ years of experience in a pharma environment, regulatory authority, or academia/R&D.
  • At least 1 year of direct Regulatory Affairs experience.

✔️ Education:

  • Degree in Life Sciences or related discipline (MSc preferred).

✔️ Skills & Competencies:

  • Strong knowledge of regulatory affairs, post-approval changes, and dossier management.
  • Experience handling international regulatory submissions and large variations.
  • Project management, documentation skills, and proactive communication.
  • Fluency in English (written and spoken).

🔹 Multiple openings available for various levels within License Management roles.
🔹 Final designation will be determined based on experience and knowledge during screening.

🚀 Join a team that fosters diversity, innovation, and inclusion! Apply now to be part of our mission to drive human progress.