Regulatory - Sponsor Dedicated - CMH Experience (Home-based, US or Canada)

MedStar Health; Connecticut; Remote; USD 95,000 - 176,000; Full time

Job summary

A leading biopharmaceutical organization is seeking a Regulatory Specialist to manage regulatory activities and ensure compliance in a home-based setting. Candidates should have relevant experience in regulatory affairs and strong communication skills. Benefits include a flexible PTO, health benefits, and a competitive salary range.

Benefits

Company car or allowance

Health benefits

401k match

Stock purchase plan

Performance bonuses

Flexible PTO

Qualifications

• Relevant experience in regulatory affairs is required.
• Excellent communication skills are essential.
• Ability to work independently in a home-based setting is necessary.

Responsibilities

• Manage regulatory activities and ensure compliance.
• Prepare documentation for regulatory submissions.
• Collaborate with cross-functional teams to support sponsor projects.

Skills

Communication skills

Regulatory affairs experience

Ability to work independently

Job description

Regulatory - Sponsor Dedicated - CMH Experience (Home-based, US or Canada)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model centers around the customer and the patient. We continually seek to simplify and streamline our work to make Syneos Health easier to work with and for.

Whether in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate therapy delivery because we are passionate about changing lives.

Discover what our 29,000 employees across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people through career development, supportive management, training, peer recognition, and rewards.
• We foster a Total Self culture where you can be authentic. We are dedicated to taking care of our people.
• We build a diverse, inclusive environment where everyone feels they belong.

Job Responsibilities

Include managing regulatory activities, ensuring compliance, preparing documentation, and collaborating with cross-functional teams to support sponsor projects.

Qualifications

We seek candidates with relevant experience in regulatory affairs, excellent communication skills, and the ability to work independently in a home-based setting.

Benefits include a company car or allowance, health benefits, 401k match, stock purchase plan, performance bonuses, and flexible PTO. Salary range: $95,000 - $175,700, depending on experience and qualifications.

Get to know Syneos Health: Over the past 5 years, we have worked with 94% of all FDA-approved drugs, 95% of EMA-approved products, and conducted over 200 studies across numerous sites and patients.

Learn more at http://www.syneoshealth.com

Additional Information

Tasks and responsibilities may evolve; qualifications will be considered based on experience and skills. We comply with all applicable laws and are committed to an inclusive, accessible workplace.