POSITION OVERVIEW:

The Global Regulatory Lead Partner supports Global Regulatory Leads in assigned therapeutic areas and serves as the accountable global regulatory point of contact for designated products. The individual provides regulatory leadership for life‑cycle management, maintenance of established products, and execution of global regulatory submissions. This role drives results through regulatory science expertise, strong communication, and analytical capabilities, ensuring high‑quality regulatory strategies and deliverables for assigned products.

WORK LOCATION:

Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

KEY RESPONSIBILITIES:

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

• Ensure maintenance of global registrations for assigned products, including US and EU markets.
• Lead and execute regulatory activities supporting life‑cycle management, including submission strategy development, timeline definition, prioritization, assembly review, and identification of regulatory risks/challenges.
• Manage regulatory agency communications and submissions, including responses to agency questions, labeling negotiations, updates, and periodic reports.
• Coordinate SMEs to develop response strategies and author/review responses to health authority requests.
• Support labeling discussions, updates, and filings across CCDS, USPI, SmPC, and country‑specific labels.
• Provide regulatory input for annual reports, renewal applications, and aggregate safety reports (e.g., PSURs, PADERs).
• Conduct regulatory review for tender bid applications and assess country requests for registration deletions.
• Support preparation of ancillary documents required for product registrations in global markets.
• Follow through on agency commitments and ensure timely, high‑quality regulatory deliverables.
• Conduct research and review of US, EU, and other relevant regulatory guidelines, precedence, and competitive intelligence to inform regulatory strategy.
• Collaborate with Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, and other functional partners to ensure alignment and execution of regulatory strategy.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor's degree or higher in a relevant field such as pharmaceuticals, chemistry, or regulatory affairs.

Experience:

• 5+ years of experience in regulatory affairs and/or regulatory framework of major health authorities
• Experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics. Has sufficient regulatory knowledge to integrate inputs from other countries/regions to develop a global strategy and can develop and lead execution of holistic regulatory strategy while considering risk/opportunity, timeline, resource.
• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends. Understands scientific and clinical data sufficiently to ask questions and make suggestions about cross-functional topics to influence overall development strategy and to assess regulatory implications and develop regulatory strategy.
• Regulatory experience with pre and post approval lifecycle management, interactions with Health Authorities, leading cross-functional regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
• Strong business acumen and ability to make sound decisions that contribute positively to the business.
• Strong strategic skills and the ability to balance short-term needs with long-term vision.
• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.

Skills and Attributes:

• Excellent written and verbal communication skills.
• Strong negotiating skills and ability to think creatively and develop innovative solutions.
• Strong organizational and project management abilities.
• Strong analytical skills with high attention to detail.
• Understanding of regulatory filing requirements.
• Knowledge of ICH guidance and routine regulatory maintenance requirements.
• Ability to manage multiple priorities and work independently in a fast-paced environment.
• Proactive, detail-oriented, and self-motivated with a strong work ethic.

POSITION OVERVIEW:

The Vice President, Regulatory Partnerships is a senior leadership role within the end-to-end Regulatory Strategy organization, spanning preclinical, clinical, Regulatory CMC, Regulatory Operations, and Regulatory Partnerships. This role is responsible for leading and expanding strategic regulatory partnerships, with a strong emphasis on post-approval lifecycle management, driving integrated client solutions, and accelerating commercial growth.

This leader will play a pivotal role in shaping how regulatory services are delivered across the organization by connecting scientific expertise with strategic advisory and execution, while positioning the company as a trusted partner to global pharmaceutical and biotech clients. A key focus of the role will be optimizing post-approval strategies, enhancing client delivery models, driving efficiencies, and embedding continuous improvement across engagements.

KEY RESPONSIBILITIES:

Strategic Leadership and Organizational Impact

• Lead the Regulatory Partnerships function as a core component of an integrated, end-to-end Regulatory Strategy organization
• Define and execute the strategic direction for partnerships, including post-approval and lifecycle management capabilities, ensuring alignment with broader business goals
• Build, lead, and develop a high-performing global team across the United States, India, and evaluate entry into Europe
• Partner across Regulatory Consulting, Regulatory CMC, Regulatory Operations, and other service lines to deliver seamless, client-centric solutions
• Builds a culture of rigor and accountability by establishing clear performance metrics, KPIs, and standardized processes across regulatory partnerships, enabling consistent measurement of delivery quality, efficiency, and client outcomes.

Commercial and Business Acumen

• Drive revenue growth through expansion of strategic client partnerships and development of new business opportunities, including post-approval lifecycle services
• Act as a commercial leader, contributing to pipeline development, account strategy, and revenue forecasting, in consultation with the Commercial team
• Collaborate with Commercial and Business Development teams to shape go-to-market strategies and differentiated service offerings
• Identify opportunities to expand client engagements through lifecycle management, regulatory optimization, and long-term partnership models
• Monitor industry trends, competitive landscape, and evolving regulatory requirements to inform growth strategy

Client Leadership and Partnership Excellence

• Serve as an executive sponsor for key global client relationships
• Lead and manage strategic client partnerships with a focus on long-term lifecycle support, including post-approval activities (variations, supplements, global submissions)
• Build and sustain value-driven relationships with senior client stakeholders across regions
• Ensure consistent, high-quality delivery across engagements, with a focus on scalability, predictability, and client satisfaction
• Leverage client insights and engagement learnings to continuously refine delivery models and strengthen partnerships

Operational Excellence, Efficiencies, and Continuous Improvement

• Drive operational efficiencies by standardizing processes, tools, and delivery models across regulatory partnerships
• Capture and implement learnings from client engagements to enhance quality, consistency, and speed of delivery
• Establish best practices for global post-approval lifecycle management and submission strategies
• Partner with internal teams to optimize resource models, utilization, and delivery effectiveness
• Embed a culture of continuous improvement, innovation, and knowledge sharing
• Leverages data and insights to drive decision-making, continuously refine delivery models, and ensure transparency and alignment across global teams.

Technical and Functional Expertise

• Provide deep expertise across global regulatory frameworks, including FDA, EMA, and other international health authorities, with a strong focus on post-approval requirements
• Guide teams on complex regulatory strategies across the full product lifecycle
• Maintain oversight of quality, compliance, and consistency across all client deliverables
• Contribute to thought leadership, innovation, and advancement of regulatory strategy capabilities

Global Leadership and Cultural Agility

• Lead and develop globally distributed teams, with direct experience across the United States, India, and Europe
• Demonstrate strong cultural awareness and adaptability, enabling effective collaboration across diverse teams and client environments
• Navigate the complexities of global client delivery, recognizing that client partnerships span multiple regions, regulatory bodies, and cultural contexts
• Align global teams to shared goals while respecting regional differences in communication, decision-making, and execution
• Evaluate and, if needed, support expansion into European markets, with an understanding of regional regulatory dynamics and business opportunities
• Foster an inclusive, high-performance culture that promotes accountability, engagement, and excellence across geographies

QUALIFICATIONS & EXPERIENCE:

Education

• Bachelor’s or Master’s degree in Biology, Chemistry, or a related scientific field required

Experience

• 15+ years of progressive experience in Regulatory Affairs, including significant experience in post-approval and lifecycle management
• Demonstrated experience working with the U.S. Food and Drug Administration and strong knowledge of European regulatory frameworks
• Proven experience working within both large pharmaceutical organizations and scientific consulting environments
• Track record of leading and scaling global teams across the United States, India, and Europe
• Strong commercial acumen with demonstrated success in driving revenue growth and expanding client accounts
• Experience leading complex global client engagements and managing senior stakeholder relationships
• Demonstrated ability to drive operational efficiencies, standardization, and continuous improvement
• Experience supporting or leading global regulatory partnership models or FSP-style engagements preferred

Leadership Profile

• Strategic, enterprise thinker with the ability to connect regulatory expertise to business growth
• Commercially driven with strong business and financial acumen
• Client-focused leader who builds trusted advisor relationships
• Collaborative operator who thrives in a matrixed, global organization
• Proven people leader with the ability to develop, inspire, and retain high-performing teams
• Highly adaptable, with strong executive presence and ability to influence across all levels of the organization

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, as well as to lift and carry objects such as books and files weighing up to 25 pounds. 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 PROGRAM:

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; San Diego, CA; Boulder, CO; and India.

LEGAL STATEMENT:
 
Syner-G 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 is an E-Verify employer. 

POSITION OVERVIEW:

Syner-G seeks a Manager/Senior Manager of Regulatory Affairs to provide regulatory consulting to a large, global pharmaceutical Client in the areas of Chemistry, Manufacturing, and Controls (CMC), to ensure compliance with FDA, EMA, and global regulatory requirements (with a focus on post-approval).  A successful candidate will have a proven track record of applying scientific principles to solve challenges.

WORK LOCATION:

Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

KEY RESPONSIBILITIES:

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

• Demonstrating strong ownership, initiative and accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
• Actively contributes to strategic discussions and decision-making processes.
• Possesses excellent communication skills, exhibit strong leadership potential in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
• Contribute to the development of CMC regulatory strategies and submission documents for post approval pharmaceutical products with the ability to execute tasks independently in accordance with US, EMA & global regulations and ICH guidance.
• Execute regulatory strategies by leading the authoring and review of global CMC submissions and ancillary documentation to support post-approval supplements/variations, and responses to health authority questions using established business process and submissions tools.
• Collaborate with CLIENT and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Coordinate timely and accurate responses to the Regulatory agency questions (RTQs) on CMC content.
• Responsible for regulatory operational activities including organizing, tracking, and sending submissions for publishing for the US and other International Markets.
• Provide regulatory change control assessments and strategize post-approval implementation and applicable regulatory reporting.
• Perform regulatory reviews of technical/development documents such as certificate of analysis (CoA), analytical test methods, specifications, and stability protocol/report/data.
• Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the product.
• Author/compile documentation for regulatory submission packages including post approval submissions, information request updates, and new markets registration, source of supply changes for submission to global regulatory agencies.
• Proactively ensure all regulatory documents are prepared accurately and completed in a timely manner towards project completion.
• Maintains knowledge of current FDA, EU, global regulations and guidance’s applicable to marketed products.
• Assess and communicate potential regulatory risks and product mitigation strategies.
• Identify, communicate and escalate potential regulatory issues to concerned CMC team/management, as needed.
• May manage a team of two (2) to four (4) individual contributors in support of project execution.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
• Potential for pre-approval submissions (IND/CTA/IMPD) authoring depending upon prior experience and expertise.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor’s or Master’s degree required in sciences, Pharmacy, Biological sciences, Engineering, or related field, Advanced degree preferred.

Experience:

• Minimum seven (7) years of CMC post approval submissions or relevant experience, which may include regulatory, research, manufacturing, analytical methods development, quality control, or related fields.
• Minimum 5 years’ experience in post approval CMC authoring and review of CMC sections in Module 1, 2, and 3 for the post-approval regulatory filings required.
• Demonstrated superior oral and written communication skills, as well as interpersonal skills; detail-oriented and well organized.
• Working knowledge of the US and European regulations and ICH guidances.
• Extensive knowledge of pharmaceutical development, specifications, release and stability of drug products and substances.
• Strong knowledge and experience of working in cGMP environment preferred.
• Hands on experience in regulatory systems and tools for authoring and change controls assessment is a plus (i.e. EDMS, Veeva Vault, Trackwise).
• Demonstrated ability to prioritize and handle multiple projects simultaneously.
• Proactive and self-motivated; ability to take initiative.
• Strong work ethic and desire to thrive in a fast-paced, deadline-driven environment.
• Prior Supervisory experience in pharmaceutical industry is a plus.

Skills and Attributes:

• Excellent written and verbal communication skills
• Strong organizational and project management abilities
• Ability to manage multiple priorities and work independently in a fast-paced environment
• Proactive, detail-oriented, and self-motivated with a strong work ethic