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Senior Executive-Regulatory Affairs

6+ years
Not Disclosed
10 Dec. 18, 2024
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

Senior Executive - Regulatory Affairs
Location: Bluefish Pharmaceuticals
Job Category: Regulatory Affairs

About Bluefish Pharmaceuticals:

Bluefish Pharmaceuticals, established in Sweden, is a leading generics pharmaceutical company committed to making quality medicines accessible worldwide. We create value across the entire pharmaceutical value chain, from development and manufacturing to marketing generic pharmaceuticals. With a product portfolio spanning major therapeutic areas, Bluefish is focused on providing cost-effective, high-quality generics, and expanding our global footprint.

Role Overview:

Bluefish is seeking a Senior Executive - Regulatory Affairs to support the Regulatory Affairs function in achieving its objectives. The position will report to the Lead-RA Technical and will be responsible for managing the submission process of Marketing Authorization Applications (MAAs) and ensuring regulatory compliance across the EU and other markets.

Key Responsibilities:

  • MAA Applications: Plan, compile, and submit marketing authorization applications (MAAs), variations, renewals, and other relevant maintenance activities for dedicated products within the EU.
  • Product Lifecycle Management: Oversee the product lifecycle for assigned products, ensuring that licenses are maintained and updated.
  • Health Agency Relations: Foster and maintain strong relationships with health agencies and stay up to date on relevant EU and national regulations.
  • Dossier Management: Review, compile, and prepare regulatory dossiers in compliance with ICH and eCTD formats. Follow up on dossier requirements and track changes for accuracy.
  • Health Authority Communications: Respond to comments from health authorities, preparing necessary documents and submissions within the required timelines.
  • National Submissions: Ensure accurate translations and submission of country-specific documents. Coordinate with health authorities to finalize approvals.
  • Variations & Renewals: Prepare and compile variation and renewal packages. Ensure correct documentation, calculation of fees, and timely submission.
  • Administrative Support: Maintain and update regulatory databases and tracking tools.

Candidate Specifications:

Education & Experience:

  • Life Sciences or Pharmacy graduate with 6+ years of experience in the pharmaceutical industry, specifically in Regulatory Affairs.
  • Proficient in Microsoft Word and Excel, with strong computer skills.
  • Experience in European and global new submissions and post-marketing maintenance activities.

Skills & Abilities:

  • Strong teamwork and collaboration skills.
  • Clear and transparent communication (both written and oral) with proficiency in English.
  • Assertive, proactive, and solution-oriented with a positive attitude.
  • Good problem-solving skills with a focus on achieving win-win solutions.
  • A commitment to personal development through self-learning.

Apply Now:

Interested candidates can send their resumes to hr@bluefishpharma.com.