Regulatory Project Manager

Job Title: Regulatory Project Manager
Location: India (Remote)
Contract duration: until December 2026
Hours: 155 per month
Start: ASAP
Company Overview:
Apsida Life Science is partnering with a leading global clinical research organization that provides end-to-end clinical development and regulatory consulting services to pharmaceutical, biotechnology, and medical device companies. With a strong global presence, the organization supports clients across the product lifecycle, delivering expertise in clinical research, regulatory affairs, pharmacovigilance, and market access to help bring innovative therapies to patients worldwide.
Key Responsibilities:
Responsible for the regulatory management (delivery and maintenance)of clinical assets and MAs for a portfolio of products for Ireland and UK
Is the primary interface with the local regulatory authorities
Ensure product information is compliant with MA. Ensures that the company’s product Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/ labeling are compliant with MA and with regulatory requirements
Co-ordinates national input into responses to regulatory questions and regulatory commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.
Responsible for the local management of product registration documents in regulatory databases and repositories.
Manage regulatory agency correspondence in accordance with company procedures
Notify to Regulatory agencies product quality and safety issues in an expeditious manner in accordance with company procedures
Completes Marketing Authorisation Holder (MAH) review of Periodic Quality Reviews for all registered products in responsible portfolio for which the company’s Ireland is MAH
Effective planning of regulatory activities for portfolio
Provides considered regulatory advice, leadership and expertise to brand teams and to other regulatory and cross functional groups.
Co-ordinates meetings with regulatory authorities and plays a key role in these interactions
Builds and maintains effective relationships with (not limited to) internal regulatory, medical, commercial, supply chain and clinical groups.
Takes a proactive lead and shows an ability to focus and identify key issues early and contribute fully to the development of solutions.
Requirements:
Graduate/PhD level or equivalent – Life sciences.
Experience in the pharmaceutical industry, including regulatory experience.
In depth understanding and practical experience of national or/and EU regulations, guidelines and working practices and of the regulatory issues relevant to the portfolio.
Knowledge of drug development process and regulatory affairs.
Knowledge of the commercial and medical issues pertaining to the assigned portfolio, including an awareness of competitor products and activities.
Ability to work in a complex environment.
Good interpersonal and influencing skills.
Has an understanding of the impact of the regulatory environment and proposed changes which are likely to impact the business in the medium term.
Can define regulatory strategy.
Has an in depth understanding of regulatory governance, medical and safety.
If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science: kgmphahlele@apsida.com
+44 744 134 1041
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.

Work arrangement
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