Director, Regulatory Affairs
4 weeks ago
When our values align, there's no limit to what we can achieve.
Great opportunity to use your regulatory expertise and lead a truly exceptional team
As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications; and manage client relationships.
You will:
Foster professional growth and development for your direct reports
Use your extensive Regulatory and product development clinical and non-clinical strategy experience for all phases applications in the US and Canada.
Provide expertise in interactions with regulatory agencies (such as FDA) and provides expertise on regulatory guidelines and requirements.
Interact with various stakeholders, including the writing team, subject matter experts, project leadership, and the Sponsor with a focus on high-quality deliverables.
Assist your team, as needed, in the development of regulatory submission strategies.
Utilize expertise to create efficient workflows and timelines.
Provide support to your team and utilize your expertise in regulatory writing to produce high-quality documentation for regulatory submissions.
Ensure high-quality deliverables by coordinating with the writing team, subject matter experts, project leadership and Sponsor.
Demonstrate strong project management skills to ensure on-time and high-quality project delivery.
Facilitate effective coordination and communication between stakeholders to achieve project goals.
Collaborate with cross-functional teams to ensure alignment of regulatory strategy with overall product development goals.
Implement strategies to mitigate risks and address potential challenges in project execution and staff allocation, resourcing needs.
Facilitate staff development plans and coordinates with project staffing for appropriate utilization and skill expansion.
Participate in project scoping calls, proposal preparation, and account planning for key clients.
Actively prospect and leverages new business opportunities in collaboration with Account Management
Communicate organizational vision and values to staff and promotes effective information flow.
Skills:
Management and leadership skills with proven experience coaching, motivating, developing, and retaining high performing regulatory professionals.
Consulting skills
Project management knowledge
Influencing others
Client-focused approach to work
Networking
Results orientation
Business analysis
Excellent interpersonal and intercultural communication skills, both written and verbal Teamwork and collaboration
Critical thinking and problem-solving skills
Holding people accountable
Operational leadership
Leading change
Strategic business thinking
Strong organization and planning skills with an attention to detail and ability to handle multiple tasks with accuracy.
To ensure success, you will have:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree (MSc, PhD) Preferred
10-15 years related Regulatory Affairs experience in the life sciences or consulting industries. Previous CRO or Consulting experience highly preferred
8+ years of experience in people management and leadership experience within the clinical and/or nonclinical regulatory functions
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
We have other current jobs related to this field that you can find below
-
Director, Regulatory Affairs
4 weeks ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and...
-
Director, Regulatory Affairs
4 weeks ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and...
-
Senior Regulatory Affairs Consultant
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Bring your regulatory expertise and passion for combination products to Parexel Excellent opportunity for a "cradle to crypt" Medical Device Regulatory professional to share their expertise with multiple clients with innovative technologies Parexel's incredible Regulatory Consulting...
-
Senior Regulatory Affairs Consultant
1 month ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Bring your regulatory expertise and passion for combination products to Parexel! Excellent opportunity for a “cradle to crypt” Medical Device Regulatory professional to share their expertise with multiple clients with innovative technologies! Parexel’s incredible Regulatory...
-
Senior Regulatory Affairs Consultant
4 weeks ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Bring your regulatory expertise and passion for combination products to Parexel! Excellent opportunity for a “cradle to crypt” Medical Device Regulatory professional to share their expertise with multiple clients with innovative technologies! Parexel’s incredible Regulatory...
-
Senior Regulatory Affairs Consultant
3 weeks ago
nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Bring your regulatory expertise and passion for combination products to Parexel! Excellent opportunity for a “cradle to crypt” Medical Device Regulatory professional to share their expertise with multiple clients with innovative technologies! Parexel’s incredible...
-
Director/Senior Director, CPMS
2 weeks ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve.Parexelis one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding in North America.We currently have a tremendous opportunity for aDirector/Senior Director, CPMS -...
-
Director/Senior Director, CPMS
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeWhen our values align, there's no limit to what we can achieve.Parexelis one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding in North America.We currently have a tremendous opportunity for aDirector/Senior Director, CPMS -...
-
Director/Senior Director, CPMS
4 weeks ago
nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding in North America. We currently have a tremendous opportunity for a Director/Senior...
-
Director/Senior Director, CPMS
4 weeks ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding in North America. We currently have a tremendous opportunity for a Director/Senior...
-
Vice President, Technical
1 week ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve.As one of our ex-FDA colleagues describes it: “you get to see a lot of cool stuff very quickly”.If you’re looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there’s no better place to be than as aVice President, Technicalon Parexel’s...
-
Vice President, Technical
1 month ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. As one of our ex-FDA colleagues describes it: “you get to see a lot of cool stuff very quickly”. If you’re looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there’s no better place to be than as a Vice President,...
-
Vice President, Technical
1 month ago
nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. As one of our ex-FDA colleagues describes it: “you get to see a lot of cool stuff very quickly”. If you’re looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there’s no better place to be than as a Vice President, Technical ...
-
Vice President, Technical
4 weeks ago
nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. As one of our ex-FDA colleagues describes it: “you get to see a lot of cool stuff very quickly”. If you’re looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there’s no better place to be than as a Vice President, Technical ...
-
Vice President, Technical
4 weeks ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. As one of our ex-FDA colleagues describes it: “you get to see a lot of cool stuff very quickly”. If you’re looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there’s no better place to be than as a Vice President,...
-
Medical Director, Oncology
4 weeks ago
nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. During the last five years, Parexel has participated in more than 1,000 Oncology and Hematology clinical projects. The range of services includes compound clinical development planning, collaboration with feasibility, protocol writing or optimization, medical monitoring and...
-
Medical Director, Oncology
3 weeks ago
nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. During the last five years, Parexel has participated in more than 1,000 Oncology and Hematology clinical projects. The range of services includes compound clinical development planning, collaboration with feasibility, protocol writing or optimization, medical monitoring and...
-
Associate / Medical Director - Nephrology
3 days ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve.Join Parexel for an impact on global health way beyond the possibilities of an individual!Working at Parexel’s Medical Sciences team is about enhancing your understanding of diseases and the drug development process. It’s about learning from colleagues with multiple specializations and with...
-
Nagpur, India Orica Full timeAbout Orica At Orica, it’s the power of our people that leads change and shapes our futures. Every day, all around the world, our people help mobilise vital resources essential to progress. Established in 1874, we have grown to become the world leader in mining and civil blasting with a diverse of team of more than 13,000 across the world. ...
-
Medical Director, Oncology
1 month ago
Nagpur, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. During the last five years, Parexel has participated in more than 1,000 Oncology and Hematology clinical projects. The range of services includes compound clinical development planning, collaboration with feasibility, protocol writing or optimization, medical monitoring and...
