AM - Regulatory Affairs (APAC, Africa, MENA & GCC)Global Pharma Co.

Greetings! & very warm welcome to BEST-FIT Recruitment Riders,

Trusted Emerging Recruitment & Executive Search Partner

professional career opportunity

Please see the following position summary:

• Client Name:

  Australian Global Pharma specialist in Pharmaceutical & Medical Device

• Position:

  Sr. Executive / Assistant Manager - Regulatory Affairs

• Markets:

  APAC, Africa, MENA & GCC

• Products:

  Injectable, Solid Oral, Topical

• Location: Bangalore

Job Profile:

Regulatory Strategy & Submissions:

• Develop and implement regulatory strategies for product registration across APAC, Africa, MENA & GCC regions.
• Prepare, review, and submit high-quality regulatory dossiers across APAC, Africa, MENA & GCC regions
• Assist in regulatory risk assessment and provide input during product development, launch, and post-marketing phases.
• Prepare, compile, review, and submit dossiers (CTD/eCTD/ACTD/NeeS or country-specific formats) for new product registrations, variations, renewals, and line extensions.
• Liaise with local regulatory agencies and partners/distributors for query responses, clarifications, and approvals.
• Responses to regulatory queries and deficiency letters
• Coordinate with global teams to obtain required documentation for submission.

Product Lifecycle Management:

• Maintain Marketing Authorisations (MAs) for assigned products in the APAC, Africa, MENA,GCC markets.
• Ensure that labeling, artwork, and product information (SmPC, PIL, and labels) are compliant with current APAC, Africa, MENA,GCC legislation.
• Manage post-approval changes, labeling updates, and renewals across assigned markets.
• Monitor timelines and ensure timely submission of periodic safety update reports (PSURs) and risk management plans (RMPs), as applicable.

Regulatory Communication:

• Act as a liaison with the APAC, Africa, MENA & GCC courtiers regulatory bodies to facilitate the approval and maintenance of products.
• Respond to questions and requests from health authorities efficiently and professionally.

Cross-functional Collaboration:

• Coordinate with R&D, QA, QC, Production, Packaging Development, and Supply Chain teams to gather necessary documentation for submissions.
• Work closely with business development and commercial teams for regulatory inputs on product feasibility and market expansion.

Documentation & Database Management:

• Maintain regulatory databases and tracking systems for submission and approval status.
• Review and approve artworks, product information leaflets, and packaging materials to ensure regulatory compliance.

Regulatory Intelligence & Compliance:

• Monitor regulatory intelligence and update management on changes in regulatory guidelines and their impact on existing/future submissions.
• Monitor changes in the APAC, Africa, MENA,GCC regulatory environment
• Interpret and communicate regulatory updates to internal stakeholders.
• Ensure regulatory processes are compliant with internal SOPs and global regulatory standards (EMA, ICH, MHRA).
• Ensure compliance with regional regulatory requirements, guidelines, and legislations.

Desired Profile:

• B.Pharm / M.Pharm / M.Sc. (Life Sciences/Pharmaceutical Sciences) with 5 to 8 years of regulatory affairs experience in the pharmaceutical industry with exposure to APAC, Africa, MENA & GCC markets.
• Strong knowledge of regulatory guidelines across APAC, Africa, MENA & GCC regions.
• Expertise in CTD, ACTD, and country-specific dossier formats.
• Good understanding of pharmaceutical product lifecycle management.
• Strong coordination, follow-up, and documentation skills.
• Excellent communication and liaison skills for interacting with health authorities and distributors.
• Detail-oriented with strong project management and organizational abilities.
• Excellent communication & interpersonal skills.
• Strong analytical & problem-solving abilities.
• Effective communication skills for interactions with internal teams and external partners.
• Meticulous attention to detail.
• Ability to manage multiple priorities and work under pressure.

Recruiter Details:

BEST - FIT Recruitment Riders

G-7, Amrit Complex,

Opp: Mahavir Jain Vidhyalaya & Jain Derasar,

R.V. Desai Road, Near Goyagate Circle,

Vadodara-390001, Gujarat, India

Mobile: 09722052906, 09722042906

E-Mail: career@bfrr.in

Website: www.bestfitrecruitment.co.in