Associate Director, Global Regulatory Lead, Gi & Inflammation

6+ years

149,100.00 - 234,300.00

Boston

10 Nov. 27, 2024

Job Description

Job Type: Full Time Education: PharmD/PhD/MD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Associate Director, Global Regulatory Lead, GI & Inflammation
Location: Boston, MA (Hybrid Work)

About Takeda:
At Takeda, we are dedicated to transforming patient care through the development of novel specialty pharmaceuticals and patient support programs. We are a global leader in R&D, focused on pushing the boundaries of what is possible to deliver transformative therapies to patients worldwide. As a certified Global Top Employer, Takeda offers stimulating career opportunities and fosters an inclusive, innovative, and collaborative work environment.

Role Overview:
Join Takeda as an Associate Director in Global Regulatory Affairs (GRA) within the GI & Inflammation therapeutic area. You will define and lead global regulatory strategies, providing strategic and tactical advice to cross-functional teams to ensure timely and efficient product development while maintaining compliance with regulatory requirements. You will manage complex projects and contribute to the broader success of Takeda's programs.

How You Will Contribute:

Regulatory Strategy Leadership:
- Lead and define global regulatory strategies for complex or multiple projects within the GI & Inflammation therapeutic area.
- Represent the Global Regulatory Teams (GRT) at project meetings, and ensure the execution of the regulatory strategy is aligned with changing business and regulatory needs.
- Provide tactical guidance to cross-functional teams and collaborate to ensure global regulatory compliance.
- Monitor and communicate potential regulatory risks and develop solutions in collaboration with the team and management.
FDA Submissions & Health Authority Interactions:
- Oversee all U.S. FDA submissions and approvals for assigned projects.
- Lead and manage FDA meetings, serving as the primary point of contact with health authorities.
- Work with regional regulatory leads, functions, and vendors to ensure timely, compliant global submissions.
Cross-Functional Collaboration & Leadership:
- Lead or contribute to departmental and cross-functional initiatives, including due diligence for licensing opportunities and joint interactions with health agencies and HTA bodies.
- Influence the regulatory and access strategy for product development by anticipating trends and updating regulatory strategies as needed.
Team Leadership & Vendor Oversight:
- Oversee direct reports or junior staff, providing guidance and ensuring compliance with regulatory processes.
- Manage vendor relationships and oversee regulatory activities and submissions related to assigned projects.

Minimum Requirements/Qualifications:

Education & Experience:
- Bachelor’s degree in a scientific discipline (advanced degree, such as PharmD, PhD, or MD, strongly preferred).
- 6+ years of pharmaceutical industry experience, including at least 4 years in regulatory affairs or a combination of 6+ years in regulatory and related experience.
- Experience in reviewing, authoring, or managing components of regulatory submissions.
- Strong knowledge of drug development and regulatory requirements, including FDA, EU, and global markets.
Skills & Expertise:
- Ability to interpret complex scientific data and guide teams in developing appropriate regulatory strategies.
- Strong oral and written communication skills, including negotiation, risk mitigation, and adherence to timelines.
- Ability to work effectively within global teams, contributing to common goals and objectives.
Regulatory Strategy and Risk Management:
- Ability to proactively identify and solve regulatory issues, including offering creative solutions and risk mitigation strategies.
- Strong leadership skills with the ability to influence cross-functional teams and stakeholders.

Travel Requirements:

Willingness to travel as required, up to 10-30% of the time.

Compensation & Benefits:

Salary Range (U.S. Based Location - Boston, MA):
- $149,100.00 – $234,300.00 (Base salary range). The actual salary offered will depend on qualifications, experience, and location.
- Eligible for short-term and long-term incentives, medical/dental/vision insurance, 401(k) plan with company match, disability coverage, life insurance, and more.
- Paid time off, including up to 120 hours of vacation and 80 hours of sick time annually.

Why Takeda:
At Takeda, we are committed to creating a diverse workforce and providing equal employment opportunities for all employees. Join us to be part of an organization that values your contributions and offers a supportive, inclusive environment where you can make a real difference in patient care.

EEO Statement:
Takeda is an equal opportunity employer and ensures that all employees and applicants are treated fairly, without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, or any other protected characteristic.

Apply today to become a part of a world-class R&D organization committed to advancing health and a brighter future for all.

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Associate Director, Global Regulatory Lead, Gi & Inflammation

Job Description

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