Strategist, GRA CMC

Pharmaceutical Research Associates, Inc • $100K — $130K *
Blue Bell, PA 19422In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted 2 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant scientific discipline or healthcare-related field
  • Minimum of 5 years in regulatory affairs within pharma or biotech
  • Strong understanding of global regulatory requirements
  • Proven success in regulatory submissions and agency interactions
  • Strong communication, leadership, and problem-solving skills

Responsibilities

  • Develop regulatory strategies for global clinical trials
  • Provide guidance on regulatory compliance issues
  • Collaborate with cross-functional teams to meet regulatory objectives
  • Lead interactions with regulatory agencies and submissions
  • Stay updated on regulatory changes and industry trends

Benefits

  • Competitive base salary and performance incentives
  • Health programs including medical, dental, and vision coverage
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programs and wellbeing resources
  • Learning and development opportunities through training and career pathways
Full Job Description
Strategist, GRA CMC

As a Senior Manager, Regulatory Strategy at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

You will oversee regulatory affairs operations, balancing quality, timelines, and stakeholder expectations.

Key responsibilities include:
  • Developing and implementing regulatory strategies for global clinical trials.
  • Providing expertise and guidance on regulatory requirements and compliance issues.
  • Collaborating cross-functionally with teams to ensure regulatory objectives are met.
  • Leading interactions with regulatory agencies and preparing submissions.
  • Keeping abreast of regulatory updates and industry trends to inform strategy.


Your Profile:

You will have a strong background in regulatory affairs, with proven management experience and a commitment to quality delivery.

Required qualifications and experience:
  • Bachelor's degree in a relevant scientific discipline or healthcare-related field
  • Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
  • Strong knowledge of global regulatory requirements and guidelines.
  • Proven track record of successful regulatory submissions and interactions.
  • Excellent communication, leadership, and problem-solving skills.


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.

About Pharmaceutical Research Associates, Inc

Pharmaceutical Research Associates, Inc Careers

Joining Pharmaceutical Research Associates, Inc presents an unparalleled opportunity to become part of a leading team in the pharmaceutical research industry. This company stands as a beacon of innovation, leadership, and professional growth.

Explore Job Opportunities

Pharmaceutical Research Associates, Inc is actively seeking skilled professionals eager to impact the world of pharmaceuticals and healthcare. With a variety of job opportunities available, candidates can find positions that match their skills and career ambitions perfectly.

Experience the Culture and Benefits

At Pharmaceutical Research Associates, Inc, the culture thrives on diversity, innovation, and a commitment to employee growth. The company offers comprehensive benefits designed to support the health, well-being, and financial security of each team member. From diversity training to leadership programs, employees are equipped with resources to thrive both professionally and personally.

Internship Programs

For those starting their career journey, Pharmaceutical Research Associates, Inc provides robust internship programs. These opportunities allow interns to work alongside experienced professionals, gaining invaluable industry insight and enhancing their resume through practical, hands-on experience.

Professional Growth and Development

Career advancement is a cornerstone of employment at Pharmaceutical Research Associates, Inc. The company supports career growth through professional development programs, networking opportunities, and leadership training, ensuring that every team member has the tools to succeed.

Innovative Work Environment

Pharmaceutical Research Associates, Inc is at the forefront of pharmaceutical innovation. The team is dedicated to pioneering research that leads to new discoveries and solutions in healthcare, offering employees a chance to contribute to meaningful projects that push industry boundaries.

Join the Team

Pharmaceutical Research Associates, Inc is hiring! Search open positions that align with your professional skills and interests. The company values curious, creative, and solution-driven team players ready to drive success in the pharmaceutical industry.

Stay Connected

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Apply Now

Ready to take the next step in your career? Explore the positions available, tailor your resume, and prepare for an interview with Pharmaceutical Research Associates, Inc. Discover how your expertise can contribute to the global impact of this dynamic company.

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Learn more about Pharmaceutical Research Associates, Inc
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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