Senior Manager, Regulatory Affairs

Posted 2 Days Ago
Be an Early Applicant
Hiring Remotely in Mumbai, Maharashtra, IND
In-Office or Remote
Senior level
Pharmaceutical
The Role
Lead and manage a regulatory affairs team as the EU CTR subject-matter expert, providing strategic regulatory guidance, SOP oversight, audit support, regulatory consulting to clients, and capability building through coaching, training, and process improvement initiatives.
Summary Generated by Built In

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

A Senior Manager within R&A provides leadership and direction to consultants, senior consultants and managers, actively managing employee performance and development. A Senior Manager acts as a role model and provides a broad range of consulting services and may be responsible for a specific function/technical area.

Key Responsibilities

  • Extensive experience in Regulatory Affairs, including expertise in EU Clinical Trials Regulation (EU CTR) and experience leading and developing teams.
  • Act as the Subject Matter Expert (SME) for the EU Clinical Trials Regulation (EU CTR), providing strategic regulatory guidance and ensuring compliant implementation.
  • Drive capability building within the team through coaching, mentoring, training, and knowledge-sharing initiatives.
  • Contribute to organizational EU CTR-related projects, process improvements, and strategic initiatives.
  • Support the development, review, and maintenance of functional Standard Operating Procedures (SOPs).
  • Provide support during regulatory audits and inspections.
  • Deliver regulatory consultancy and client-focused guidance, fostering strong stakeholder partnerships.
  • Lead and manage a team, ensuring performance, development, and operational excellence.

Skills and Competencies

  • Strong expertise in EU Clinical Trials Regulation (EU CTR) and associated regulatory requirements.
  • Ability to interpret regulatory intelligence, assess impact, and translate requirements into practical processes and implementation plans.
  • Solid understanding of regulatory operations, workflows, and compliance standards.
  • Excellent stakeholder management and communication skills, with experience collaborating across global teams and clients.
  • Strong analytical, problem-solving, decision-making, and risk mitigation capabilities in a dynamic environment.
  • Demonstrated ability to work collaboratively and influence cross-functional teams in a consultative manner.

Skills Required

  • Extensive experience in Regulatory Affairs with strong expertise in EU Clinical Trials Regulation (EU CTR)
  • Proven experience leading, developing, and managing regulatory teams
  • Act as SME for EU CTR, providing strategic regulatory guidance and implementation plans
  • Experience developing, reviewing, and maintaining functional SOPs
  • Experience supporting regulatory audits and inspections
  • Ability to deliver regulatory consultancy and maintain strong client/stakeholder relationships
  • Capability building skills including coaching, mentoring, training, and knowledge sharing
  • Strong analytical, problem-solving, decision-making, and risk mitigation skills

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

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The Company
HQ: Raleigh, NC
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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