Regulatory Affairs Manager/Sr. Manager – Pharmaceutical APIs

Title:

Location:

Experience:

About LOXIM

LOXIM

Singapore, Japan, Indonesia, Vietnam, Thailand,

Why Join LOXIM?

• Be part of a

  globally recognized organization

  known for quality, innovation, and excellence.
• Work in a

  dynamic, growth-driven environment

  that fosters creativity and continuous learning.
• Collaborate with

  industry experts

  on projects that make a real impact.

The Role

Regulatory Affairs Manager

Key Responsibilities

• Lead regulatory submissions for generic API applications such as DMF’s, ASMF’s, CEP’s, variations, renewals, responses to regulatory deficiencies, post approval changes, and lifecycle management.

• Lead the preparation and submission of Drug Master Files (DMFs), CEPs, and other regulatory dossiers for APIs in compliance with region-specific requirements across the US (FDA), Canada (Health Canada), EU (EMA), UK (MHRA), Japan (PMDA), Brazil (ANVISA), Mexico (COFEPRIS), Colombia (INVIMA), South Africa (SAHPRA), and select African regulatory agencies.

• Liaise with regulatory authorities (CDSCO, USFDA, EMA, EDQM etc.) and respond to queries.

• Review the internal regulations and guidelines to proactively develop solutions to potential regulatory queries and coordinate with the team to resolve them.

• Support regulatory inspections and customer audits by providing necessary documentation and justifications

• Maintain regulatory databases and proper archival of submissions/approvals.

• Stay up to date with the latest regulatory rules and regulations, SOP ‘s, foreign policies, guidelines (including but not limited to ICH, GMP, FDA, stability), and industry standards.

• Coordinate with cross-functional teams (QA, QC, R&D, Analytical Development, Manufacturing, Packaging, Contract Manufacturers, Business Development) to gather data for submissions and proactively support them with communicating the regulatory requirements.

• Monitor changes in global regulatory frameworks and assess impact on product portfolio.

• Ensure documentation and dossiers are audit-ready and compliant.

• Support product labeling, packaging, and promotional material reviews.

• Mentor and develop regulatory team.

Qualifications & Skills

• Graduate or Post–Graduate Degree in Regulatory Affairs, Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline.

• Proven experience in handling regulatory submissions for multiple geographies.

• Strong understanding of ICH guidelines, GMP, and regulatory pathways.

• Excellent communication and stakeholder management skills.

• Detail-oriented with a proactive mindset.

Are you passionate about navigating the complex landscape of pharmaceutical regulations?

Do you thrive in a fast-paced environment where precision, compliance, and innovation intersect?

If so, we’d love to meet you!

jobs@loxim.com