Glaxo Smith Kline

CMC Regulatory Affairs Associate Director

Glaxo Smith Kline

Collegeville, PA 19426, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

The CMC Regulatory Affairs Associate Director at Glaxo Smith Kline is responsible for providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives. The successful candidate will have a collaborative, proactive, and highly organized approach to their work, and will bring a wealth of knowledge and experience in CMC Regulatory Affairs.To be successful in this role, you must have a minimum of 10 years of experience in CMC Regulatory Affairs, with a minimum of 7 years in a leadership role. The ideal candidate will also possess a demonstrated track record of successfully managing CMC Regulatory activities and initiatives, a deep understanding of regulatory requirements and guidelines, and excellent communication and interpersonal skills. Additionally, experience with strategic planning, problem solving, and working within a global team environment is required.

Where is this job?
This job is located at Collegeville, PA 19426, USA
Job Qualifications
  • Pharmacy

  • Bachelor's Degree In Regulatory Affairs

  • Excellent Written And Verbal Communication Skills

  • Excellent Organizational And

  • Medicine

  • Or A Related Scientific Field

  • At Least Years Of Relevant Experience In Regulatory Affairs

  • Demonstrated Knowledge Of Global Regulatory Procedures And Guidelines

  • Ability To Work In A Team-Oriented Environment

  • Proven Ability To Develop And Implement Strategies For Regulatory Submissions

Required Skills
  • Risk Management

  • Quality Assurance

  • Project Management

  • Data Analysis

  • Risk Analysis

  • Regulatory compliance

  • Regulatory documentation

  • Regulatory Affairs

  • Clinical Trials

  • Regulatory Strategies

  • Regulatory Submissions

  • Regulatory Negotiations

  • Pharmacovigilance

  • Good Manufacturing Practices

  • Fda Compliance

Soft Skills
  • Communication

  • Leadership

  • Problem Solving

  • Time management

  • Interpersonal Skills

  • creativity

  • flexibility

  • Critical thinking

  • Teamwork

  • Adaptability

Compensation

According to JobzMall, the average salary range for a CMC Regulatory Affairs Associate Director in Collegeville, PA 19426, USA is between $82,800 and $112,800 per year. This range is based on the job description, experience, and skills of the individual hired to fill the role.

Additional Information
Glaxo Smith Kline is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedFebruary 21st, 2023
Apply BeforeMay 22nd, 2025
This job posting is from a verified source. 
Reposted

Apply with Video Cover Letter Add a warm greeting to your application and stand out!

About Glaxo Smith Kline

GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, London. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham, GSK was the world's sixth largest pharmaceutical company as of 2015, after Pfizer, Novartis, Merck, Hoffmann-La Roche and Sanofi.

Frequently asked questions

Get interviewed today!

JobzMall is the world‘ s largest video talent marketplace.It‘s ultrafast, fun, and human.

Get Started