Head - Regulatory Affairs (UK / EU) with Foreign based Global Pharma

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:

Position: Sr. Manager / AGM (Head)

Markets: UK & Europe

Products: Solid Oral, Injectable, Topical

Job Location: Bangalore

Office Timing: 09:00 AM to 05:00 PM

Working Days: Monday to Friday & 2nd & 4th Saturday

Role & responsibilities

To lead and manage all regulatory activities related to pharmaceutical formulations for the UK and EU markets, ensuring timely submissions, approvals, and compliance with MHRA, EMA, and related regional regulations. The incumbent will be responsible for strategizing and executing regulatory pathways for new product registrations, variations, renewals, and life-cycle management.

Regulatory Strategy & Planning:

• Develop and implement regulatory strategies for UK & EU submissions.
• 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 file dossiers in CTD/eCTD formats for new product registrations, renewals, and variations.
• 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.
• Maintain regulatory databases, tracking systems, and ensure timely license renewals.

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).

Team Leadership & Development:

• Lead a team of regulatory professionals; provide training, guidance, and performance review.
• Foster a culture of regulatory excellence and proactive compliance.

Preferred candidate profile

• B.Pharm / M.Pharm / M.Sc with 12 to 18 yrs experience in Regulatory Affairs with Pharmaceutical company preferably focused on the UK / EU markets.
• Strong knowledge of UK & EU regulatory frameworks (MHRA, EMA, ICH).
• Experience with MHRA submissions is a must.
• Experience with generic, branded, or biologic drug submissions.
• Experience with regulated market submissions and product registrations is mandatory.
• Prior exposure to regulatory interactions, query responses, and audits.
• 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.
• 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 documentation, communication, and leadership skills.
• Ability to manage multiple priorities and work under pressure.
• Excellent communication & interpersonal skills.
• Strong analytical & problem-solving abilities.
• Meticulous attention to detail.

Clients' Offer:

• Competitive compensation and benefits package.
• Opportunities for professional development and career growth.
• A collaborative, inclusive, and innovative work environment.
• Exposure to international markets and cross-functional projects.

Special Note: This is a work from office position & hence candidates are requested to apply only if willing to work from office. This role does not offer a work-from-home option. (Remote / Hybrid Working).

Recruiter's Contact Details:

Dharmesh Sikligar

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: 09558802906

Website: www.bestfitrecruitment.co.in