AM - Regulatory Affairs with Australian Global Pharma Company

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:

  Assistant Manager - Regulatory Affairs

• Markets: UK & Europe

• Products: Solid Oral, Injectable, Topical

• Location:

  Bangalore

Job Profile:

Regulatory Strategy & Planning:

• Support the development and execution of regulatory strategies for product registration and lifecycle management in the UK market.
• Assist in regulatory risk assessment and provide input during product development, launch, and post-marketing phases.
• Stay updated with MHRA and EU regulatory requirements, and ensure integration into company processes.

Dossier Preparation & Submission:

• Prepare, review, and submit high-quality regulatory dossiers including

1. Marketing Authorization Applications (MAA)

2. Post-approval variations (Type IA/IB/II)

3. Renewals

4. Line extensions

5. Clinical Trial Applications (if applicable)

6. Responses to regulatory queries and deficiency letters

7. Compile and maintain product documentation in eCTD, NeeS, or paper format (as required).

8. Coordinate with global teams to obtain required documentation for submission.

Product Lifecycle Management:

• Maintain Marketing Authorisations (MAs) for assigned products in the UK.
• Ensure that labeling, artwork, and product information (SmPC, PIL, and labels) are compliant with current UK/EU legislation.
• 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 MHRA and other regulatory bodies to facilitate the approval and maintenance of products.
• Respond to questions and requests from health authorities efficiently and professionally.

Cross-functional Collaboration:

• Work closely with cross-functional teams including R&D, QA, Manufacturing, Supply Chain, Pharmacovigilance, and Medical Affairs.
• Ensure consistent regulatory input during formulation, scale-up, process validation, and batch release.

Regulatory Intelligence & Compliance:

• Monitor changes in the UK and EU regulatory environment (including post-Brexit developments).
• Interpret and communicate regulatory updates to internal stakeholders.
• Ensure regulatory processes are compliant with internal SOPs and global regulatory standards (EMA, ICH, MHRA).

Desired Profile:

• B.Pharm / M.Pharm / M.Sc with 5 to 10 yrs experience in Regulatory Affairs with Pharmaceutical company preferably focused on the UK / EU markets.
• Experience & knowledge in the preparation of major regulatory submissions & supportive amendments or supplements.
• Must have exposure in UK or EU.
• Experience with MHRA submissions is a must.
• Knowledge of post-Brexit regulatory landscape, including the separation of EU and UK procedure.
• Proficient in preparing & compiling eCTD/NeeS format dossiers using publishing tools (e.g., Extedo, Lorenz).
• Strong knowledge of SmPC, PIL, and labeling requirements under UK and EU laws.
• Familiarity with Common Technical Document (CTD) structure & ICH guidelines.
• Experience with generic, branded, or biologic drug submissions.
• Exposure to CP (Centralised Procedure), MRP (Mutual Recognition Procedure), & DCP (Decentralised Procedure) is a plus.
• Working knowledge of Quality Management Systems (QMS) & pharmacovigilance frameworks.
• Certification or training in regulatory affairs (e.g., from RAPS or TOPRA).
• Excellent communication & interpersonal skills.
• Strong analytical & problem-solving abilities.
• 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