Deputy Manager / Manager - Regulatory Affairs - (Derma)

Role & responsibilities

Health Canada ANDS (Abbreviated New Drug Submission):

• Comprehensive knowledge of Health Canada's ANDS pathway for generic drug approvals.
• Skilled in compiling complete ANDS dossiers (Modules 15) and interpreting regulatory guidance.
• Experienced in responding to Clarifax and NSNs with scientifically robust justifications.
• Proficient in eCTD submissions and managing post-approval changes (Level I/II).

Drug Master File (API):

• Expertise in DMF referencing and coordination with API manufacturers for compliant submissions.

EU & UK Generic Drug Registration

In-depth understanding of EMA centralised, decentralised, and MRP procedures.

• Skilled in MHRA regulatory pathways post-Brexit, including MAA submissions and PSURs.

Electronic Submissions & Publishing:

• Extensive experience in eCTD publishing, SPL submissions, and troubleshooting ESG-related issues.

Labeling:

• Proficient in FDA-compliant SPL labelling lifecycle management.

ROW Regulatory Strategy:

MENA: Experienced with Saudi FDA, UAE MOHAP, Egypt EDA.LATAM: Knowledge of ANVISA, COFEPRIS, and regional dossier requirements.

Australia: Skilled in TGA dossier compilation and bioequivalence documentation

Preferred candidate profile

A Master's degree in Pharmacy with prior experience in Regulatory affairs.

A minimum of 13 years of experience in regulatory affairs with a strong focus on dermatology and generic drug products.

Proven track record of successful drug registrations in EU/UK, US, and ROW regions.

Thorough understanding of regulatory guidelines, processes, and documentation requirements.

Excellent knowledge of EU/UK, US, MENA, LATAM, and TGA regulations.

Strong analytical skills with the ability to interpret complex regulatory guidelines and requirements.

Exceptional communication skills to effectively interact with internal teams and regulatory authorities.

Detail-oriented with a strong commitment to accuracy and compliance.

Proficiency in using regulatory submission software and databases.

Ability to work independently and manage multiple projects simultaneously.

Problem-solving skills to address challenges and develop creative solutions.

Strong organizational skills with the ability to meet tight deadlines.