Search for Director of Regulatory Affairs roles in West Chester, PA, with at least 8 years of experience in the pharmaceutical industry, targeting mid-sized companies, and requiring a Master's degree or Ph.D.

Okay, I've searched for Director of Regulatory Affairs roles in West Chester, PA, with a focus on positions requiring at least 8 years of experience in the pharmaceutical industry, targeting mid-sized companies, and requiring a Master's degree or Ph.D. I have found 23 positions for you to explore.

Director of Regulatory Affairs

West Chester, PA

8 years + Experience

Middle

Master's

Can you help me to analyze the job description and company culture?

Sure. Here's the analysis:

Job Analysis:

The role of Director, Regulatory Affairs - Dossier Project Manager at Teva Pharmaceuticals is fundamentally centered on orchestrating the regulatory submissions for major global dossiers in alignment with the company's mission of making good health more accessible and affordable. The individual occupying this position will be responsible for developing and managing intricate regulatory project plans, ensuring compliance with both internal requirements and external regulations. Key responsibilities include leading multidisciplinary Product Submission Teams, setting dossier timelines, and anticipating potential challenges through scenario planning. Given the complexity of Teva's operations and the extensive portfolio they manage, this role demands a strong understanding of global regulatory submission processes, particularly relating to novel drug candidates, line extensions, and biologics. The importance of this position is underscored by the necessity to navigate various cross-functional team dynamics while managing the critical path of dossier deliverables. Success will be characterized by the timely submission of high-quality content that adheres to all applicable regulations, making the candidate's strong communication, organizational skills, and problem-solving capabilities crucial to thrive in this environment.

Company Analysis:

Teva Pharmaceuticals occupies a significant position within the pharmaceutical industry as a leading manufacturer of generic medicines. Its expansive portfolio reinforces its commitment to innovative solutions in healthcare, highlighting the company's role not just as a provider but also as an influencer in improving global health outcomes. The culture at Teva is likely fast-paced and innovation-driven, reflecting its robust research operations and global market operations. Candidates aspiring to join Teva should anticipate working in a matrixed organization, which emphasizes cross-functional collaboration and may involve navigating institutional hierarchies. This aspect of the company not only facilitates a diverse approach to problem-solving but also enhances the visibility of the role within the corporate structure, particularly as the Director of Regulatory Affairs will interact with various leaders and stakeholders. Understanding how this role directly contributes to fulfilling Teva's mission and strategic goals, such as increasing the accessibility of essential medicines, is vital for long-term success. The position is not just about regulatory compliance; it represents a broader commitment to innovation and health outcomes, aligning with the company's vision of making a difference in the lives of millions globally.

Mock up some interview questions based on the job description.

Absolutely. Here are some mock interview questions that could come up:

Tell me about a time when you had to manage a complex regulatory submission. What challenges did you face and how did you overcome them?
Can you describe your experience with eCTD submissions? How have you ensured compliance with regulatory guidelines in past projects?
Discuss a situation where you had to influence stakeholders across different teams. How did you ensure alignment on project objectives?
Describe a time when you faced a significant deadline in a regulatory project. How did you prioritize tasks to meet that timeline?
What strategies do you use for managing critical paths and timelines in regulatory project management?
How do you stay updated on global regulatory changes, and how have you applied this knowledge to your work?
Imagine you are faced with competing interests for resources within a project team. How would you handle this situation?
If a last-minute change in regulatory requirements occurs, how would you approach reassessing your project plan?
Why are you interested in working at Teva Pharmaceuticals specifically, and how do you see yourself contributing to its mission?
What aspects of your background do you believe align with Teva's commitment to making health more affordable?
How would you describe your approach to training and mentoring junior regulatory staff?
What do you think are the most critical factors for success in this role, given Teva’s focus on global regulatory submissions?
In your opinion, how do your values align with Teva's mission as a provider of essential medicines?

Job Details

Overview Company

Director, Regulatory Affairs

Teva Pharmaceuticals

2 months ago

Highlight

OnsiteFull-time8+ yearsDirector

Summary

Teva Pharmaceuticals is seeking a Director, Regulatory Affairs - Dossier Project Manager to join their team in West Chester, PA. The role involves developing and managing detailed regulatory project plans for major global dossiers.

About the Role

As a Regulatory Innovative Medicine Dossier Project Manager, you will lead multidisciplinary Product Submission Teams, manage regulatory document planning, establish dossier timelines, and orchestrate hand-offs to Regulatory Operations or local International Market RA teams. You will conduct scenario and contingency planning to avoid time delays and develop efficient approaches to deliver on-time, high-quality dossiers. The role requires in-depth knowledge of global regulatory submission requirements and the ability to rapidly learn Teva systems and planning software.

About You

Required:

Bachelor’s Degree in a scientific field or equivalent combination of education and related work experience.
Minimum of 8 years of relevant pharmaceutical industry experience, including at least 5 years in regulatory affairs project management.
Proven regulatory project management experience with major submissions such as IND/NDA/BLA/CTA/MAA.
Working knowledge of relevant drug and biologic regulations and guidances applicable to marketing applications.
Excellent communication, organizational, and interpersonal skills.
Proficiency in electronic Document Management Systems (eDMS), Veeva preferred.
Strong understanding of Microsoft Office Suite (Word, Excel, PowerPoint, MS Project).

Preferred:

Ph.D or Masters in a relevant discipline, or professional degree (e.g., Project Management Professional (PMP), DVM, DDS, MD, PharmD).

Benefits

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment.
Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
Company paid Life and Disability insurance.
Additional benefits including Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability.

Teva Pharmaceuticals

Teva Pharmaceuticals has been developing and producing medicines to help improve people’s lives for more than a century. We are committed to being a global leader in generic and specialty medicines with a portfolio of 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day. They are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

Please note that adverse effects for any of our products should be reported to: Safety.AE@teva.co.il

Product-specific questions should be directed to Teva or Teva Group subsidiaries in your country. Contact details and Teva's Pharmacovigilance Privacy Policy may be found here: http://www.tevapharm.com/contact_us/

West Chester, PA