Contract, Global Regulatory Affairs CMC Fellow (Boston, MA- Hybrid)

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

.

*** Candidate must be located in Boston, MA ****

Job Description:

Job Objective

The Global Regulatory Affairs CMC Fellow will play a key role in supporting regulatory strategy development and execution of RA CMC activities related to Chemistry, Manufacturing and Control (CMC) of assigned program. This internship offers a unique opportunity to gain hands-on experience in Regulatory Affairs (RA), with a specific focus on Regulatory Affairs Chemistry, Manufacturing, and Controls (RA CMC) strategy development. Gain experience in RA and RA-CMC guidance/strategy in Biotech company.

Tasks/Responsibilities

• Coordinate regulatory CMC activities such as process improvement initiatives, and team meetings.

• Support CMC regulatory lead for submissions in coordination with Technical Operations and Quality in accordance with global regulations and regulatory guidance

• Research Regulatory guidance and precedence for drug development, registration, and/or post-approval product life cycle management.

• Completing all assigned tasks and assisting with day-to-day operations. 

• Participating in meetings, workshops, and other learning opportunities. 

• Observing and learning from experienced staff members. 

• Gaining knowledge of company policies, protocols, and processes. 

• Taking detailed notes and liaising with Managers, Supervisors, and other senior staff. 

• Fulfilling any requirements and meeting goals set out at the start of the Internship. 

• Following all company regulations, and health and safety codes. 

• Preparing documents and updating records. 

Experience / Qualifications

• Bachelor’s degree in life science - Scientific discipline (Biology, chemistry, molecular biology, biomedical engineering)

• PharmD, Masters in Pharmaceutical Sciences, or Masters in Regulatory Affairs preferred

• Excellent written, verbal, communication and interpersonal skills.

• Proficiency in Microsoft Office suite

• Superb attention to detail.

• A positive attitude and willingness to learn.

• Excellent time management skills.

• This is a one (1) year Talent Pipeline Program and the candidate/applicant must be able to complete the entire one-year program

• Fellow must be a recent college graduate​

For consideration, each applicant MUST answer the three (3) questions below in your cover letter to be considered for this one-year PTC Talent Pipeline Program.

• Why do you want to be part of this program? 

• In what ways do you believe you can impact the future? 

• What interests you most about this opportunity?

​

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Click here to return to the careers page