VP, Regulatory Affairs, Strategy

COMPANY OVERVIEW:

Syner-G BioPharma Group is an organization with roots to the Greater Boston area started by industry leaders in 2007 who saw a niche in the pharmaceutical consulting space and leveraged their subject matter expertise and industry knowledge to grow an organization through hard work, trusted relationships, a collaborative approach, and delivering best-in-class client services.  

We are helping to enhance human health. Through our expertise, insight, consulting and management skills, we enable clients in their quest to bring life-saving and life-enhancing products to patients. We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery and approval process. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, Syner-G employees play an instrumental role in maintaining our reputation across the globe as an integrated pharmaceutical science consulting organization. 

Syner-G has recently been honored with BioSpace’s prestigious "Best Places to Work" 2024 award. This recognition is a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, leadership and innovation. 

At Syner-G, we recognize that our team members are our most valuable asset.  Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

POSITION OVERVIEW:

The VP, Regulatory Affairs, Strategy is a senior leadership role responsible for guiding clients through complex regulatory processes, particularly in clinical development and application filings. This role oversees the development and execution of regulatory strategies across various modules, ensures compliance with FDA and international guidelines, and drives business growth through client engagement and business development activities. This position will work cross functionally with CMC technical, QA/Compliance and Medical writing teams to enable timely filing and successful development and regulatory approval of life-saving drugs.

WORK LOCATION:

This position is eligible for remote work based on company requirements, with no minimum in-office requirement. Domestic and international travel may be required for this position (Up to 20%).

JOB FUNCTIONS:

(This list is not exhaustive and may be supplemented and changed as necessary.)

• Guide clients on strategic decisions, agency meetings, and regulatory filings, with emphasis on clinical development, BLA preparations, and compliance.
• Develop, review, and implement regulatory strategies across all modules (clinical, non-clinical, labeling, drug substance, and drug product).
• Lead business development activities, including client outreach, webinars, marketing materials, and scoping calls, while identifying new opportunities for growth.
• Oversee regulatory submissions (i.e., INDs, BLA, NDA) and provide Non-Clinical/Clinical leadership, ensuring compliance with FDA and international requirements.
• Be the Regulatory Lead on behalf of the client for FDA/Health Authority interactions on key topics/issues during the entire lifecycle of drug development (Pre-IND to NDA/BLA approval). 
• Mentor and lead a team of regulatory professionals, managing staffing, resource allocation, and talent development.
• Act as a client lead, handling communications, regulatory strategy, and engagement across multiple projects.
• Collaborate with clients and internal teams to ensure alignment on timelines, strategy, and regulatory communications.
• Support vertical heads with financial reporting and profitability tracking across client accounts.
• Actively participate in external professional meetings (e.g. DIA/RAPS) communicating innovative strategies and thought leadership to advance drug development.

QUALIFICATIONS AND REQUIREMENTS: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential duties.

Education: 

Technical Experience:

• Extensive experience (15+ years) in regulatory affairs, including agency interactions and strategic regulatory planning.
• Experience in leading teams in filing of INDs and NDAs/BLAs all the way to successful approval and launch of commercial products.
• Expertise across all phases of drug development, including biologics, pharmaceuticals, oncology, orphan drugs, and pediatric studies.
• In-depth knowledge of FDA regulations, international guidelines, and the ability to advise on fast-track analysis, pediatric studies, and emergency inquiries.
• Strong project management skills, with a proven ability to lead teams, prioritize multiple projects, and maintain compliance across global submissions.
• Broad technical knowledge and experience in managing small and large molecules, including innovative regulatory strategies

Knowledge, Skills, and Abilities:

• Proven leadership experience in managing teams, projects, and client relationships within a pharmaceutical or biotech environment.
• Strong communication skills, with the ability to mentor, educate, and influence a diverse group of stakeholders.
• Ability to work in a fast-paced, dynamic environment, managing multiple projects and clients while ensuring regulatory compliance and alignment with business goals.
• Proven leadership and experience in designing the strategy and leading Health Authority interactions to achieve successful outcome.  
• Business acumen, with a focus on business development, marketing, sales support, and client engagement.
• Strong leadership and people management skills, fostering collaboration, consensus-building, and team development.

ESSENTIAL FUNCTIONS: 

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars.  This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; Boulder, CO; and Chennai, India.

EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER

Syner-G BioPharma Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.