Source Job

US

  • Drive growth of Regulatory Science and Medical Writing services across pharmaceutical, biotechnology, and life sciences clients.
  • Lead strategic sales efforts, identify client needs, and partner cross-functionally to deliver tailored solutions supporting regulatory approvals.
  • Serve as the primary liaison between client and company for all sales-related activities, enhancing visibility and market presence.

Regulatory Affairs Medical Writing Sales Business Development

20 jobs similar to Senior Business Development Director – Regulatory & Medical Writing

Jobs ranked by similarity.

US

  • Serve as a regulatory representative on multidisciplinary program teams, supporting health authority interactions and global submissions for biologics in development.
  • Contribute to regulatory plans across the product lifecycle, from early clinical development through registration and lifecycle management.
  • Manage submission activities including INDs/CTAs, amendments, annual reports, and briefing documents, ensuring compliance with US/EU regulations and ICH guidelines.

Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.

US

  • Develops and directs global regulatory strategy to obtain and maintain product approvals across key regions.
  • Serves as primary regulatory contact for health authorities and leads cross-functional regulatory sub-teams.
  • Identifies regulatory risks and provides strategic guidance for product development and lifecycle management.

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients with severe metabolic and endocrine disorders. It is a publicly traded company driven by scientific innovation, collaboration, and integrity.

Global

  • Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
  • Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
  • Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

United States Unlimited PTO

  • Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products.
  • Lead and oversee interactions with FDA, EMA, and other global regulatory agencies.
  • Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages.

Enveda reinvents drug discovery by harnessing nature's intelligence, identifying new medicines four times faster than the industry standard. The company achieved unicorn status after a $150M Series D in 2025, has an award-winning culture recognized by Newsweek and Forbes, and values creativity, collaboration, and deep respect for each team member.

US Canada

  • Drive growth by identifying and converting high-value upsell opportunities while maintaining accurate forecasts and strong client engagement.
  • Own account strategy through comprehensive plans aligned to customer priorities, and build deep executive relationships to unlock new opportunities.
  • Lead the full sales cycle from discovery and solution development to negotiation and close, delivering value by aligning Clarivate's solutions to customer challenges.

Clarivate is a global leader in trusted and transformative intelligence, providing data, insights, analytics, and workflow solutions across research and innovation. The company employs thousands and fosters a collaborative, high-performance culture focused on empowering life sciences and healthcare customers.

United States

  • Identifies and closes business opportunities for biospecimen services.
  • Develops and maintains strong client relationships to expand existing business.
  • Manages a team of Business Development Directors and guides training and strategy.

Precision Medicine Group provides biospecimen services to pharmaceutical and biotech companies. The company emphasizes collaboration, client relationships, and innovation, with a team of experts supporting business development.

EMEA

  • Lead and execute commercial strategy for medical devices regulatory services across the EMEA region.
  • Drive revenue growth, market expansion, and sales performance through effective planning and monitoring.
  • Build and maintain strong relationships with key customers, stakeholders, and strategic partners.

The company operates in the medical devices and regulatory services space across the EMEA region. It fosters an inclusive and collaborative culture with a focus on innovation, sustainability, and societal impact.

US

  • Support regulatory and quality processes to ensure compliance with applicable requirements, focusing on product design, development, and manufacture of medical devices.
  • Assist in drafting regulatory submissions for domestic and worldwide commercialization and provide guidance on product labeling and lifecycle planning.
  • Evaluate regulatory impact of changes, manage product recall activities, and participate in internal and third-party quality audits.

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. The company is dedicated to developing better solutions for life from discovery to diagnosis and fosters an innovative culture for talented individuals to solve tough problems.

US

  • Ensure product claims, labeling, and regulatory documentation meet FDA and FTC requirements for dietary supplements.
  • Work cross-functionally with Brand, Product, Quality, and Marketing teams to translate regulatory frameworks into actionable guidance.
  • Support GMP compliance, audits, and process improvements to strengthen regulatory operations at scale.

The company is a partner organization managing applications and next steps for a role in consumer health. They are a science-led organization with a growing portfolio of microbiome and nutrition-focused innovations.

US

  • Lead a high-performing sales team of Clinical Account Managers in the Mid-Atlantic region to drive demand creation and execute launch strategies.
  • Develop strong customer relationships, analyze market dynamics, and leverage competitive insights to accelerate product performance.
  • Model integrity and ensure all commercial activities adhere to regulatory and compliance standards while fostering a culture of ownership and accountability.

Sobi is a biopharmaceutical company dedicated to developing and delivering innovative therapies for people with rare diseases. With over 1,700 employees globally, they foster a collaborative, patient-first culture that empowers each team member to make a difference.

US

  • Build and maintain strong client relationships, acting as a trusted advisor and driving peer-to-peer education programs.
  • Manage and mentor account team members, setting performance goals and fostering professional growth.
  • Oversee budgets, timelines, and compliance, ensuring seamless execution and client satisfaction.

Real Chemistry is a global healthcare communications and marketing agency serving top pharmaceutical and biotech companies. The company's culture is rooted in collaboration and a commitment to excellence, with employees described as impact-obsessed and innovative.

US

  • Review, annotate, and amend publication manuscript drafts to tight deadlines.
  • Work on rapid turnaround deliverables following guidance set by Sci Comms Solutions Lead.
  • Liaise with Authors to take manuscripts to submission.

Sorcero's medical AI platform transforms life sciences decision-making, accelerating patient access to life-saving treatments. Sorcero is a Certified B Corp headquartered in Washington, DC, recognized by over a dozen awards, including Fast Company's Most Innovative companies of 2024.

US

  • Build partnerships with hospitals and clinics to secure clinical placement sites for students.
  • Manage relationships with existing clinical partners and match students to sites in a timely manner.
  • Collaborate with university partners and legal teams to secure contracts and ensure regulatory compliance.

Keypath Education is a leading global edtech company that partners with universities to create online education programs. They are a rapidly growing international team certified as a Great Place to Work, valuing community, collaboration, and lifelong learning.

UK

  • Rapidly respond to inquiries and generate new client business with prospective accounts in eClinical applications.
  • Coordinate interaction with customer-facing teams to drive revenue growth and partnerships.
  • Serve as subject matter expert in clinical trials market landscape and manage contract negotiations.

Medrio develops eClinical applications for clinical trials. We are a growing company with a culture of collaboration, ingenuity, and excellence.

UK Spain South Africa Greece Portugal Hungary

  • Lead authoring and development of high-complexity Phase II-IV clinical regulatory documents for a top pharma partner.
  • Own the end-to-end medical writing process from planning through final delivery, ensuring alignment with strategy and timelines.
  • Coordinate cross-functional teams across geographies and facilitate comment resolution to drive document development.

Fortrea delivers solutions that bring life-changing treatments to patients faster. They are a global organization that empowers employees to shape their own career path with comprehensive training and management support.

US

  • Develop, execute, monitor, and adapt strategic MSL stakeholder engagement plans.
  • Lead high-quality scientific exchange through both proactive and reactive interactions.
  • Identify and communicate insights, trends, and activities of other Medical Affairs organizations.

They focus on engaging key opinion leaders (KOLs) and healthcare providers in high-quality scientific exchange. They drive insight generation and contribute to the development and execution of medical strategy.

US

  • Lead and develop a team of Solution Sellers to drive growth across digital engagement solutions for small and emerging biopharma segments.
  • Define and optimize go-to-market strategies, collaborating with product and analytics teams to shape segment-specific offerings.
  • Serve as a strategic advisor to clients and represent IQVIA Digital at leadership meetings and industry events.

IQVIA Digital provides omnichannel marketing solutions and healthcare technology for the life sciences industry. IQVIA is a large global organization with a collaborative culture focused on improving patient outcomes.

Latin America Europe 2w PTO

  • Own the full sales cycle from prospecting to closing, targeting U.S. home-services business owners.
  • Build strategic partnerships and run multi-channel outreach including cold calls, emails, and LinkedIn.
  • Manage a clean CRM pipeline in GoHighLevel and attend weekly reviews to drive performance.

Veta Virtual is a talent solutions company that connects high-growth clients with skilled professionals. They focus on a supportive, performance-driven culture with remote teams.

US

  • Develop and execute strategic sales initiatives for implant management software solutions across complex hospital environments.
  • Manage the full enterprise sales cycle, including prospecting, negotiation, forecasting, and deal closure.
  • Build relationships with senior healthcare stakeholders, including hospital executives and clinical leaders.

This position is listed on behalf of a partner company, who manages all applications and next steps. Jobgether uses an AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly against the role's core requirements.

US

  • Plays an essential role supporting Global Medical Information / Medical Content Development Team on content development-related engagements.
  • Writes and creates medical and scientific content related to Medical Affairs, Medical Information and Medical Communications.
  • Drives the client document development process from gathering materials and developing scientifically rigorous content to facilitating document review.

EVERSANA delivers next-generation commercialization services to the life sciences industry, helping bring innovative therapies to market and supporting patients. They have over 6,000 employees, embracing diversity and inclusion to improve patient lives around the world.