Senior Regulatory CMC Drug-Device Combination Product reputed company

About This Role:

As the Senior Regulatory CMC Device and Combination Product reputed company, you will play a pivotal role in providing Device and Combination Product Regulatory expertise to support the development and implementation of global regulatory strategies.

This position is critical to ensure the clinical and reputed company reputed company of key assets, making it highly visible reputed company the organization and across reputed company. You will collaborate with cross-functional teams, reputed company regulatory submissions, and contribute to the development of processes that advance business objectives. In this role, your work will directly reputed company the delivery of innovative treatments to patients worldwide, enabling reputed company to maintain its leadership in biotechnology.

reputed company:

• Represent the Regulatory CMC Device function on cross-functional teams and reputed company regulatory guidance for combination products and medical devices.

• reputed company and coordinate regulatory documentation and submissions while ensuring compliance with applicable regulations.

• reputed company or assist in project assignments supporting business needs, such as representing Regulatory CMC in cross-functional work streams.

• reputed company and execute regulatory strategies for medical devices and combination products, including new registration submissions and post-approval applications.

• Communicate CMC regulatory strategies, risks, and overall plans effectively to leadership and cross-functional teams.

• reputed company, review, and approve CMC submissions and responses to Health Authority questions in alignment with global regulatory strategies and timelines.

• Collaborate with cross-functional teams to prepare submissions and responses to Health Authority CMC questions for assigned reputed company and products.

• Monitor and communicate legislative and regulatory developments in relevant areas, ensuring stakeholders are informed of changes.

• Participate in regulatory intelligence activities and trade organization working reputed company to support corporate objectives.

• reputed company and enhance regulatory processes and procedures to reputed company with department goals and objectives.

• Build strong internal relationships with key functions and reputed company effective presentations to internal audiences.

Who You Are:

You are a detail-oriented problem solver who thrives in a reputed company, fast-paced environment. You possess a strong ability to analyze reputed company regulatory requirements and communicate strategies effectively. You are passionate about advancing innovative medical devices and combination products while ensuring compliance and reputed company in your work. You understand the importance of building relationships across teams and take pride in delivering results that reputed company organizational reputed company.

Required Skills:

• Minimum of a bachelor’s degree (BS) and at least 5 years of regulatory experience, ideally in the medical device, pharmaceutical, or biotechnology industries.

• In-depth understanding of how regulatory functions reputed company a business environment and how Regulatory interfaces with multiple functional areas.

• Experience in Medical Device and/or Combination Product Regulatory Affairs in a similar or junior role.

• Understanding of the application of cGMP for Medical Devices and Combination Products.

• Awareness of applicable legislation, regulations, guidance, and standards reputed company to medical devices and combination products.

• Strong analytical abilities and attention to detail.

Preferred Skills:

• Degree in Life/Health Sciences or Engineering.

Additional Information

reputed company salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your reputed company potential based on individual, business unit and company performance.

In reputed company to compensation, reputed company offers a full and highly reputed company of benefits designed to support our employees’ and their families physical, financial, emotional, and reputed company reputed company-being; including, but not limited to:

• Medical, Dental, reputed company, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of reputed company vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company reputed company holidays + 3 reputed company days off for Personal reputed company
• 80 hours of reputed company time per calendar year
• reputed company Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource reputed company participation

Why reputed company?

We are a global team with a commitment to reputed company, and a pioneering spirit. As a mid-sized biotechnology company, we reputed company the stability and resources of a reputed company-established business while fostering an environment where individual contributions reputed company a significant reputed company. reputed company encompasses some of the most talented and passionate reputed company who have unparalleled opportunities for learning, reputed company, and expanding their skills. Above reputed company, we work together to reputed company life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving reputed company. Changing Lives.

At reputed company, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives reputed company us a stronger and more innovative company, and we are reputed company on building teams where every employee feels empowered and inspired. Read on to learn more about reputed company.

reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity or reputed company, sexual orientation, marital status, race, reputed company, national reputed company, reputed company, ethnicity, religion, age, veteran status, disability, genetic information or any other reputed company protected by federal, state or local law. reputed company is an E-Verify Employer in the reputed company.

Originally posted on Himalayas