Senior Regulatory Affairs Associate (FDA expertise)
About the role
Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel!
We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership.
As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical support for product launches, integrations, and lifecycle management activities.
This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence
cross‑functional teams in a fast‑changing environment.
Key Responsibilities Documentation & Compliance
- Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements.
- Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes).
- Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals.
Regulatory Submissions
- Review, prepare, and submit dossiers; negotiate with HAs to secure approvals.
- Provide local input for change control and post-approval requirements.
- Collaborate with global functions to obtain documentation aligned with local requirements.
Audit & Inspection Support
- Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure.
- Provide local expertise and responses to inspection queries.
Cross-Functional Collaboration
- Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes.
- Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies.
Strategic Leadership
- Lead regulatory strategies for product launches and integrations at the affiliate level.
- Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships.
- Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation.
Education
- Bachelor’s degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent.
- Advanced degree (Master’s or PhD) preferred in law, legal affairs, or natural sciences.
- Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus.
Experience
- 3–5+ years of local regulatory knowledge and experience in a health authority-facing role.
- Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes.
- Proven expertise in managing regulatory submissions, timelines, and cross-functional teams.
- Strong project management and leadership skills.
- Experience influencing Commercial Operations stakeholders and driving business-critical decisions.
- Demonstrated ability to adapt and succeed in rapidly changing environments.
Based upon the individual, the role can be home-based in Canada or the United States.
About Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are:
• Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming.
We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
Senior Regulatory Affairs Associate (FDA expertise)
About the role
Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel!
We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership.
As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical support for product launches, integrations, and lifecycle management activities.
This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence
cross‑functional teams in a fast‑changing environment.
Key Responsibilities Documentation & Compliance
- Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements.
- Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes).
- Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals.
Regulatory Submissions
- Review, prepare, and submit dossiers; negotiate with HAs to secure approvals.
- Provide local input for change control and post-approval requirements.
- Collaborate with global functions to obtain documentation aligned with local requirements.
Audit & Inspection Support
- Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure.
- Provide local expertise and responses to inspection queries.
Cross-Functional Collaboration
- Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes.
- Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies.
Strategic Leadership
- Lead regulatory strategies for product launches and integrations at the affiliate level.
- Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships.
- Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation.
Education
- Bachelor’s degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent.
- Advanced degree (Master’s or PhD) preferred in law, legal affairs, or natural sciences.
- Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus.
Experience
- 3–5+ years of local regulatory knowledge and experience in a health authority-facing role.
- Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes.
- Proven expertise in managing regulatory submissions, timelines, and cross-functional teams.
- Strong project management and leadership skills.
- Experience influencing Commercial Operations stakeholders and driving business-critical decisions.
- Demonstrated ability to adapt and succeed in rapidly changing environments.
Based upon the individual, the role can be home-based in Canada or the United States.
About Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are:
• Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming.
We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.