Senior Executive - Regulatory Affairs

Department

Should be from Pharmaceutical/Lifesciences Industry.

Job Overview:

We are looking for an experienced and detail-oriented Senior Executive Regulatory Affairs (RA) to join our team.

The ideal candidate will be responsible for compiling, reviewing, and submitting regulatory dossiers for both ROW and regulated markets in compliance with EU CTD guidelines.

This role demands a strong understanding of global regulatory requirements, coordination across cross-functional teams, and the ability to independently handle client and authority queries.

Key Responsibilities

• Prepare master dossiers as per EU CTD (Common Technical Document) guidance.
• Review key regulatory documents including:
• Product Development Reports (PDR)
• Specifications and STPs for excipients, APIs, and finished products
• Control Drug Processes (CDP)
• Nitrosamine risk assessments
• Elemental and residual impurity reports
• Assessment reports, stability protocols, and reports
• Process validation protocols and reports
• Drug Master Files (DMFs)
• Submit regulatory dossiers across

  ROW (Zambia , Peru , Ethiopia , Canada , Singapore , Malaysia , Venezuela , Philippines) and Regulated markets (EU , UK , Brazil , AUS) .

• Handle and respond to MoH (Ministry of Health) and client queries in a timely and compliant manner.
• Coordinate with clients for regulatory meetings and calls.
• Collaborate effectively with internal teams including Plant, Project Management (PM), R&D, FRD, and external stakeholders like CROs & CMOs.
• Review dossiers prepared by junior team members and provide necessary guidance.
• Handle EU variation filings for Type IA, IB, and Type II submissions.
• Maintain proper registration databases and submission records.

Required Skills & Qualifications

• B.Sc B.Pharm / M.Pharm / M.Sc in a relevant discipline.
• 5-7 years of hands-on experience in Regulatory Affairs, preferably in pharmaceutical formulations.
• Strong knowledge of EU CTD format and global regulatory guidelines.
• Proficiency in dossier compilation and review for regulated and semi-regulated markets.
• Experience with variation filings and managing regulatory lifecycle of products.
• Excellent documentation, analytical, and communication skills.
• Ability to multitask and work collaboratively across teams.

Preferred Attributes

• Self-driven with a proactive approach to problem-solving.
• Strong attention to detail and compliance-oriented mindset.
• Ability to mentor junior team members