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Director, Regulatory Affairs CMC

Employer
Syner-G BioPharma Group
Location
Working from Home
Start date
Nov 13, 2023

View more

Discipline
Regulatory, Regulatory Affairs, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time

Job Details

  

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, growing the company and geographical footprint across the globe to be an industry leader in integrated biopharma consulting services across the CMC, Regulatory Affairs and Medical Writing verticals supporting small molecule, biologics and medical device development and delivery.

 

We offer an outstanding total rewards package, including a competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous unlimited paid time off program, 13 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.

 

POSITION OVERVIEW:

 

Syner-G BioPharma Group is seeking an exceptional science professional to join our Regulatory Affairs team. The candidate will be responsible for supporting our Biopharmaceutical and/or Pharmaceutical clients throughout the product development process and through commercialization. A successful candidate will have a proven track record of learning and applying scientific principles to solve regulatory challenges. Seeking a candidate who exhibits a passion to help patients by enabling the expeditious development and approval of high-quality, life-saving medicines.  

 

WORK LOCATION:

 

The Director, Regulatory Affairs position is eligible for remote work based on company requirements, with no minimum in-office requirement.  

JOB FUNCTIONS:

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

 

  • Collaborate with internal business development team as well as potential new clients and existing clients to both establish new business accounts and grow existing accounts.
  • Proactively provide guidance and insight on current trends in the regulatory landscape to clients and colleagues.
  • Provide strategic regulatory strategies and regulatory support to clients to support their programs across development and registration to maintain and grow projects.
  • Partner across Syner-G to build integrated program support for clients.

 

 

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:  

  • A bachelor’s or advanced degree (e.g., B.S., M.S., Ph.D.) in biology, biochemistry, chemical engineering, or relevant discipline is required.   

 

Technical Experience:

  • 10+ years’ experience in regulatory CMC supporting IND/CTA/NDA/MAA applications, preparation of and support for global health authority meetings (FDA required) and experience with special regulatory designation applications (Orphan Drug Designation, Fast Track, Breakthrough etc) and accelerated approval pathways preferred. 
  • Extensive knowledge and understanding in CMC product development, manufacturing processes and control strategies, analytical method development and validation, and quality environment for pharmaceutical products.
  • Demonstrated ability to develop strategic regulatory approaches to clinical development programs.
  • Extensive knowledge of pharmaceutical development. Expertise in the drug development process and analytical methods, preferred.
  • Excellent written and verbal communication skills as well as interpersonal skills
  • Demonstrated ability to prioritize and manage multiple projects with minimal supervision.
  • Proficient ability to read, analyze and interpret technical documents and health authority regulations.
  • Extensive knowledge of the US and European regulations and ICH guidance
  • Fluent in MS Office (Word/Excel/PowerPoint) suite of products and proficient with CMC documentation in the CTD format is required
  • Demonstration of leadership and ability to work and think independently.

 

 

Knowledge, Skills, and Abilities:

  • Ability to work with diverse internal and external (client) stakeholders, and at commercial contract manufacturers.
  • Detail-oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment.
  • Ability to troubleshoot problems, work within a team, and independently design, develop, and execute experiments.
  • Ability to manage several projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.

 

 

 

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. 

 

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.

 

 

 

 

Company

Syner-G Bio Pharma 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, growing the company and geographical footprint across the globe to be an industry leader in integrated biopharma consulting services across the CMC, Regulatory Affairs and Medical Writing verticals supporting small molecule, biologics and medical device development and delivery. Key values of collaboration, a one-team mindset, and benevolence were not only the cornerstone of initial success, but also the culture that has been created since our founding, placing our people at the center of our company.

As an employee, you will experience us leading with our core mission, “To develop and inspire pharmaceutical consulting professionals”. We encourage open, two-way communication throughout the company and provide a supportive and encouraging working environment that allows employees to reach their greatest potential, celebrating those who live our values every day. We realize the vital role a positive work/life balance plays in establishing a rewarding, productive, and long-term career. As a result, a flexible, family-friendly work environment is a key element of our culture and is one of the reasons people want to work (and stay) here!

We offer an outstanding total rewards package, including a competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous unlimited paid time off program, 13 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 locations in Greater Boston, Raleigh, NC, Boulder, CO, and Chennai, India.

 

CONNECT

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Company info
Website
Phone
508.460.9700
Location
100 Pennsylvania, Ave, Suite 310
Framingham
MA
01701
United States

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