New · posted Oct 15
Precigen · Biotechnology
Sr Manager, Global Promotional Regulatory Affairs
- Germantown, MD
- On-site
- Full-time
- Manager
Open until filled
The role
The Senior Manager, Global Promotional Regulatory Affairs is responsible for providing regulatory leadership and guidance for promotional, medical, and other external communications while supporting the development and maintenance of product labeling for assigned products. Reporting to the SVP, Regulatory Affairs, this role serves as a key regulatory partner to internal teams to ensure promotional communications and labeling activities comply with applicable regulatory requirements while supporting business objectives.
What you need
EDUCATION AND EXPERINCE
- Bachelor’s degree in life sciences or relevant field.
- 5+ years of experience in regulatory affairs in promotional materials, global labeling or related discipline.
- Strong understanding of FDA regulations and guidelines.
DESIRED KEY COMPETENCIESnice to have
- Ability to understand and execute the company’s mission and values.
- Self-motivated and independently minded.
- Strong verbal and written communication skills and cross-functional collaboration abilities.
- Self-organizer, meticulous hands-on habits, keen attention to detail.
- Ability to build working relations throughout the organization to achieve business goals.
- Strong time management, organizational, and execution skills.
- Ability to manage multiple projects in a fast-paced environment.
- Excellent judgement and decision-making skills.
- Problem solving and risk-mitigation skills.
EOE MFDV
What you'll do
- Lead the promotional material and labeling strategy and activities for assigned products and therapeutic areas.
- Provide regulatory guidance and manage regulatory aspects of the review and approval for product promotional materials and labeling.
- Lead label working groups and promotional review meetings, as needed. Collaborate with cross-functional reviewers to determine next steps and approval status.
- Ensure that content, quality, accuracy, and format of submissions comply with applicable internal policies procedures as well as applicable regulatory guidance and requirements.
- Partner effectively with internal teams as needed to ensure thorough, timely and efficient review and completion of all materials.
- Provide guidance and expertise on new marketing concepts and promotions tactics for assigned products.
- Support interactions with Healthcare Authorities including discussions related to label negotiations, and promotional materials for advisory comments for full approval and accelerated approval products.
- Monitor evolving regulations, enforcement trends, guidance documents, and industry developments impacting promotional and labeling activities and communicate implication and recommendations to internal stakeholders.
- Other duties as assigned.
Where you'll work
Germantown, MDOn-siteOpen in Maps (opens in a new tab)
More jobs in Germantown, MDJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Manager roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $143,000 | $149,500 | $172,250 |
Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 74 open Labeling & Promotion roles on Regulatory Jobs, with the titles they carry most. Not Precigen's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions6
- Collaboration and leadership6
- GMP and compliance2
- Documentation and SOPs2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Precigen on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Regulatory2 67%
- Quality1 33%
By level
- Manager2 67%
- Senior & Principal1 33%
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Sr Manager, Global Promotional Regulatory Affairs at Precigen
Open until filled.