Senior Manager, Regulatory Affairs

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Position : Senior Manager - Regulatory Affairs CMC

Location

Chennai / Bangalore / Trivandrum / Home - Based

The Role

The Senior Manager - Regulatory Affairs, provides knowledge on CMC strategy within the Global Regulatory Affairs team which forms part of our Strategic Regulatory Services Group.

As a Senior CMC, you will participate in the provision of Regulatory CMC expertise in strategic drug development across multiple areas. Activities encompass early and late stage drug development, marketing application and approval, and product maintenance. This position will focus on the development of Biologics and Cell/Gene Therapy.

Responsibilities

• Serve as a technical expert in development, testing and manufacturing of advanced therapy medicinal products (ATMP) and resource to ICON colleagues, and clients providing advice

• Effectively manage the preparation of regulatory CMC submission documents

• Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project teams.

• Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organization as required.

• Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.

• Enthusiastically monitors for new regulatory requirements and shares key findings.

• Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.

Education/Experience

• Bachelor’s degree in a relevant discipline, preferably in a life sciences, or other healthcare field; Advanced degree (MSc., PhD., M.D., Pharm D, MBA) in the biological, medical, chemical or engineering field may be beneficial.

• 15 - 20 years of experience, minimum 5 years in biological submissions, 10-12 years in US, Canada submissions.

• Relevant experience i.e. pharmaceutical, biologics with regulatory experience in the global environment (e.g. Europe, US, Japan, China).

• Technical development, testing and manufacturing of advanced therapy medicinal products (ATMP)

• Demonstrable experience in a regulatory CMC role or in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance.

• Experience supporting business development activities and people management an asset.

• Certification in regulatory affairs (RAC) or post-secondary institution beneficial.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply