POSITION OVERVIEW:

As a Consultant II (Clinical Strategy), you will play a pivotal role in guiding clients through the complex landscape of regulatory affairs, ensuring compliance and facilitating the successful development and approval of pharmaceutical products. You will serve as a strategic partner, leveraging your expertise to navigate regulatory requirements and optimize pathways for drug submissions, focusing on clinical development activities from early stage development to late stage planning.

KEY RESPONSIBILITIES:

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

• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients.
• Handle FDA Type A, Type B, Type C and Type D meetings.
• Engage in all phases of drug development, from early-stage to post-registration.
• Develop and review regulatory documents, author IND, NDA and BLA submissions, and coordinate with Non-Clinical/Clinical teams.
• Assist clients with Non-Clinical and Clinical strategy and clinical development activities and design, draft submission documents, and review content for completeness and editorial quality.
• Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines.
• Prepare briefing documents and guide clients through regulatory requirements.
• Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement.
• Serve as the main point of contact for clients, ensuring effective communication and regulatory support.
• Mentor and train new employees in regulatory affairs, Non-Clinical/Clinical, and FDA processes.
• Facilitate the development, review, and resolution of comments on technically complex Non-Clinical/Clinical documentation for regulatory submissions.
• Partner with clients on Non-Clinical/Clinical strategy and submissions.
• Manage regulatory communications for Non-Clinical/Clinical issues with the FDA and other global regulatory authorities.

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 accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education:

• Bachelor’s degree in chemistry, pharmaceutics, biology, or a related scientific discipline; MA degree preferred.
• RAC Certification is a significant advantage; equivalent certifications or extensive experience in regulatory affairs are highly valued.

Technical Experience:

• Proficient in Microsoft Office Suite and industry-specific software tools such as Trackwise, Veeva, and ICTD.
• Strong understanding of drug development, manufacturing, and clinical development processes.
• Experience in authoring and managing Non-Clinical/Clinical and FDA sections for regulatory submissions.
• Ability to evaluate manufacturing and quality changes for regulatory impact.
• Demonstrated proficiency in regulatory information management systems and tools
• Familiarity with the ICH Common Technical Document (CTD) structure and ability to author sections within this framework.
• Experience with protocol development.

Knowledge, Skills, and Abilities:

• Strong background in drug development, biologics, and clinical trials.
• Proven experience in handling INDs, NDAs, BLAs, and global submissions.
• Demonstrated ability to adapt to client needs, providing strategic advice and tactical support across various therapeutic areas.

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.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

LEGAL STATEMENT:

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. 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.