Senior Regulatory Affairs Associate

Quanta Consultancy Services Ltd; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

An exciting opportunity awaits with a dynamic international pharmaceutical organization specializing in innovative solutions for patients with swallowing difficulties. As a Senior Regulatory Affairs Associate, you will play a crucial role in ensuring compliance with local laws and regulations while executing variations for marketing authorisations. This role requires a proactive individual with strong communication skills and a keen eye for detail. Join a forward-thinking company that values initiative and offers a collaborative environment where your contributions will make a significant impact on patient care. If you're ready to take on this challenge, apply now!

Qualifications

• Experience in regulatory affairs and compliance with local laws.
• Strong communication skills and attention to detail are essential.

Responsibilities

• Execute variations for marketing authorisations and ensure compliance.
• Develop product information text and maintain regulatory systems.

Skills

Regulatory Affairs

Communication Skills

Problem-Solving

Planning Abilities

Attention to Detail

Tools

MS Office

Job description

Senior Regulatory Affairs Associate – Contract – Pharmaceuticals

Do you relish the opportunity to work with an international pharmaceutical organisation based in the UK? If yes, then this is the assignment for you!

Our client specializes in delivering medicines for patients with swallowing difficulties, across a range of therapeutic areas.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:

1. Independently execute variations for existing marketing authorisations to be submitted as per the relevant competent authorities’ requirements and in compliance with local laws and regulations. This includes the compilation of responses to authority questions within agreed timescales. Related to sustain/maintenance projects: Active participation as regulatory affairs representative in meetings with internal & external stakeholders, working cross-functionally to achieve the business goal. As a product owner, providing comprehensive regulatory advice to support the business including change control SME.
2. Develop and approve product information text in compliance with SOPs and relevant guidelines for variations.
3. Maintain regulatory systems and provide timely notification to internal & external stakeholders in line with KPIs to ensure compliance with the marketing authorisation.
4. Support associate team members.

Desirable Experience:

1. Current awareness of legal framework and forthcoming legislation that may affect the business.
2. Understanding of the workings of global competent authorities.
3. Good understanding of variations in UK and EU; knowledge globally would be beneficial.
4. Good CMC knowledge; eCTD beneficial.
5. Shows initiative and drive, particularly when faced with a problem.
6. Demonstrates good planning abilities with flexibility and agility.
7. Excellent written and verbal communication skills essential, including good attention to detail.
8. MS-Office knowledge essential.

If this role is of interest to you, please apply now!