Regulatory-Affairs-Specialist, Regulatory-Strategist, Regulatory-Affairs-Manager Jobs

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).

About the Role

We are seeking a Senior Regulatory Strategist, Advertising & Promotion to join our team in a remote capacity. As a Senior Regulatory Strategist, Advertising & Promotion, you will serve as a trusted regulatory advisor supporting clinical research and commercial activities that advance new treatments for patients. This position plays a key role in ensuring regulatory compliance, interpreting FDA guidance, and delivering strategic regulatory insights that shape product strategy. You'll collaborate with cross-functional teams including Medical Affairs, Legal, Commercial, and Marketing, follow industry-standard regulatory processes, and contribute to regulatory excellence from strategy development through implementation. Responsibilities include providing strategic regulatory guidance on advertising and promotional materials, independently reviewing and approving promotional content, and interpreting evolving FDA guidance, with opportunities to deepen your expertise and influence regulatory strategy across the organization.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory leadership, risk mitigation, and advancing patient safety. With diverse teams and continuous learning opportunities, the Senior Regulatory Strategist, Advertising & Promotion can explore career paths and expand skills across regulatory affairs and clinical research.

Key Responsibilities

• Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams

• Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios

• Independently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards

• Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy

• Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs

• Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy

• Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications

• Lead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations

• Support and, where needed, lead regulatory review committees, driving efficient and compliant review processes

• Stay current with regulatory trends, FDA enforcement actions, and industry best practices, proactively sharing insights with internal stakeholders

• Mentor junior team members and contribute to building organizational regulatory capability

Candidate Profile

You'll thrive in this role if you bring:

• Deep knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities

• Proven ability to act as a strategic advisor and trusted partner to senior stakeholders

• Strong experience collaborating with Medical Affairs, Legal, and Commercial teams

• Demonstrated ability to independently review promotional materials and make sound regulatory decisions

• Excellent communication, influence, and stakeholder management skills

• Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset

Required Qualifications

• 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion

• Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities

• Proven ability to act as a strategic advisor and trusted partner to senior stakeholders

• Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams

• Demonstrated ability to independently review promotional materials and make sound regulatory decisions

• Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly

• Excellent communication, influence, and stakeholder management skills

• Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset

Preferred Qualifications

• Experience supporting product launches or high-visibility brands

• Familiarity with global regulatory considerations

• Prior experience leading or facilitating regulatory review committees

Benefits and Compensation

• Health, Vision & Dental Insurance

• Tuition Reimbursement

• Vacation/Holiday/Sick Time

• Flexible Spending & Health Savings Accounts

• Work/Life Balance

• 401(k) with Company match

• Pet Insurance

For a complete list of benefits, please visit www.parexel.com/us-benefits.

Parexel offers competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.

Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Originally posted on Himalayas

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at or follow us on LinkedIn and Instagram.

JOB SUMMARY:

The Associate Director, Regulatory Affairs Strategy at BioCryst Pharmaceuticals (BioCryst) will work closely with product development core teams and subteams in setting company goals and work closely with these groups in meeting company goals. This position will be responsible for developing and ensuring efficient and productive regulatory strategies and submissions for BioCryst, as well as assisting and collaborating in strategic drug development program implementation. The position will work to develop and implement key new values and added initiatives focused on the coordination of the company’s regulatory program and product development missions.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• With Director of Regulatory Affairs oversight, this position will manage initial global approvals and global post-approval activities for advanced programs working with partnering companies
• Manage and support post-approval maintenance activities for marketed products, including lifecycle management submissions in the US and internationally and support development and early-phase regulatory projects as assigned.
• Support regulatory strategies for assigned projects via researching regulations and guidelines ensuring alignment with regional requirements that will result in the on-time submission and approval of new products.
• Working with Regulatory Operations, compile, prepare and submit IND, BLA/NDA and additional US regulatory filings as necessary to implement the agreed upon strategy.
• May serve as the Global Regulatory Lead (GRL) for defined projects and deliverables that may include, and not limited to, leading identified workstreams; attend clinical study team meetings; track and keep reg subteams and program teams current with status of regulatory submissions and any changes in strategies.
• May support GRL for additional programs on defined workstreams and deliverables including in the coordination and preparation of Health Authority meetings.
• Review/revise/draft Standard Operational Procedures as required to assure compliance with Global Regulations and Guidance Documents.
• Manage regulatory timelines and manage/communicate timeline and/or content risks to Director of Regulatory Affairs Strategist or GRL ensuring that regulatory strategies are executed within those approved timelines.
• Maintains current with FDA regulations and guidance regarding INDs, BLAs/NDAs, while developing familiarity with global regulations.

• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree required with advanced degree (MS; PhD, PharmD) a plus
• Eight (8) to ten years regulatory strategy experience in the biotech/pharmaceutical industry.
• Ability to maintain high ethical standards.
• Excellent organizational skills, attention to details, and communication skills.
• Ability to work as part of a team, both in a leadership role on assigned duties and as a contributing member of the company.
• Ability to develop and maintain positive working relationships across cross-functional teams.
• Strong interpersonal skills with demonstrated ability to serve as a strong, collaborative partner with internal and external stakeholders and effective written and verbal communication and presentation skills.
• Thorough knowledge of US FDA regulations, with Global experience a plus, regarding product development (IND/CTA), BLA/NDA/MAA with a sense of curiosity driving continuous learning and program success.
• Effective written and verbal communication, presentation skills and computer literate (e.g., MS Word, MS PowerPoint, MS Excel).

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Originally posted on Himalayas