*Manager, Regulatory Affairs

Teva Pharmaceuticals; West Chester (Chester County); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Manager to join their team in West Chester, PA. This role involves evaluating change requests, maintaining regulatory tools, and ensuring compliance with health authority communications. The ideal candidate will have a strong background in the biotech or pharmaceutical industry, with experience in regulatory affairs and project management. Join a mission-driven organization dedicated to making health more accessible and affordable for millions worldwide, while enjoying a competitive benefits package and opportunities for growth.

Benefits

Comprehensive Health Insurance

401(k) with employer match

Paid Time Off

Life and Disability Protection

Tuition Assistance

Employee Stock Purchase Plan

Flexible Spending Accounts

Health Savings Account

Paid Parental Leave

Virtual Physical Therapy

Qualifications

• 2 years of experience in Regulatory Affairs or related fields.
• Experience with GXP practices and FDA regulations.

Responsibilities

• Evaluate Change Requests and provide regulatory assessments.
• Assist in compiling and reviewing applications like INDs and BLAs.

Skills

GXP including cGMP practices

US FDA Guidance Documents

Electronic Document Management Software

Regulatory Reporting Requirements

Project Management

Drug Development

Education

Bachelor’s degree in Drug Regulatory Affairs

Master’s degree in related fields

Tools

Veeva

Trackwise

Job description

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West Chester, United States, Pennsylvania, 19380

Job Id: 61795

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

How you’ll spend your day

Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester, PA office to:

• Evaluate Change Requests/Change Controls and provide accurate regulatory assessments for changes impacting applications in development such as INDs and CTAs, submitted but not yet approved applications, and approved BLA applications.
• Assist to upkeep regulatory tools like standard procedures, authoring guides, position papers, and templates.
• Communicate Health Authority communication to SMEs within the organization and archive communication per standard practice.
• Review guidance's and regulations for regions within scope of assigned projects.
• Train on internal SOPs and Work Instructions, and create and utilize job aids and reviewing tools as required.
• Assist in compiling, authoring, and reviewing applications such as INDs, IMPDs, and BLAs, associated unsolicited pre-approval changes, post-approval changes, and address requests for information.
• Perform evaluation of change in conjunction with previous health authority feedback and current guidance and regulations.
• Assist in communicating regulatory strategy to SMEs for applications.
• Assist in knowledge sharing and matrix training of new employees or new skills.

Local telecommuting permitted up to 2 days per week. 5% domestic travel and 5% international travel required.

Your experience and qualifications

Bachelor’s degree in Drug Regulatory Affairs, Pharmacy, Biology, Chemistry, or a related field and 2 years of experience in the biotech/pharmaceutical industry in Regulatory Affairs (RA) or a department that works closely with RA including Quality Assurance, Regulatory Compliance, Regulatory Operations, Quality Control, Program Management, or Dossier Development. In the alternative, employer will accept a Master’s degree in the specified fields.

Must have biotech/pharmaceutical industry experience with:

• GXP including cGMP practices
• Relevant US FDA Guidance Documents and Code of Federal Regulations
• Electronic Document Management Software; Change Control and GMP Systems such as Veeva and Trackwise
• Reviewing Technical Documents such as Manufacturing Reports, Validation Reports, or Batch Records
• Regulatory Reporting Requirements, Regulatory Assessments and Impact on Implementation
• Drug, Biologic, or Biosimilar Development
• SOP Training and Additional Work Instructions and Job Aides
• eCTD structure, content, organization, navigation, electronic submission process, and minimum document requirements
• Navigating and Reviewing Published Regulatory Submission Output
• Health Authority Requirements and Standards for Submissions
• Communicating with Health Authorities (directly or indirectly)
• Contributing to Health Authority Applications (directly or indirectly)
• Authoring and Reviewing CMC content for use in Health Authority Applications
• Understanding and communicating CMC Submission expectations to relevant stakeholders and understanding and adhering to expectations from relevant RA stakeholders
• Understanding and Communicating assessments to relevant stakeholders/understanding and adhering to assessments from relevant RA stakeholders
• Project Management, Submission Management and Change Management
• Expectations for Validation/Tech Transfer of Manufacturing DS/DP and/or Testing DS/DP
• Contributing to Authoring, Review and/or Compilation of submissions to US Applications including INDs, BLAs, NDAs, or ANDAs.
• Employer will accept 2 additional years of work experience in lieu of the Bachelor’s degree requirement.
• Employer will accept any suitable combination of education, training or experience.

5% domestic travel and 5% international travel required.

Enjoy a more rewarding choice

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

Life and Disability Protection: Company paid Life and Disability insurance.

Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Important notice to Employment Agencies - Please Read Carefully

Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.