Regulatory Affairs Consultant I
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
COMPANY DESCRIPTION:
Syner-G is a science-led strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market along with operational strategy and support. With a global team of 400 employees across North America and India our goal is to help our partners navigate the complexities of product development and accelerate their journey to market.
We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster at scale and with the highest quality.
Our team partners with a diverse range of clients across the life sciences industry supporting critical phases of the drug development lifecycle from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations enhance quality systems and ensure regulatory compliance empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide.
Syner-G was recently honored with BioSpaces prestigious Best Places to Work 2025 award for the second consecutive year along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are 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 financial rewards 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:
Syner-G BioPharma Group is seeking a Regulatory Affairs Consultant to support a global pharmaceutical client in the area of Chemistry Manufacturing and Controls (CMC) with a focus on post-approval regulatory submissions. This remote role based in Bangalore Chennai Hyderabad or Mumbai involves providing strategic regulatory guidance and operational support to ensure compliance with FDA EMA and global regulatory requirements. The ideal candidate will bring strong scientific acumen regulatory expertise and leadership capabilities.
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.)
- Lead and manage regulatory milestones for assigned products throughout the product lifecycle
- Contribute to strategic regulatory discussions and decision-making processes
- Develop and execute CMC regulatory strategies for post-approval pharmaceutical products in compliance with US EMA and global regulations
- Author and review global CMC submissions and supporting documentation for post-approval supplements variations and responses to health authority queries
- Collaborate with internal teams and external partners to ensure compliant execution of change management activities
- Coordinate timely and accurate responses to regulatory authority questions (RTQs) related to CMC content
- Manage regulatory operational activities including organizing tracking and preparing submissions for publishing
- Conduct regulatory change control assessments and strategize post-approval implementation and reporting
- Review technical documents such as certificates of analysis analytical methods specifications and stability data
- Prepare and support CMC documentation for post-approval submissions new market registrations and source of supply changes
- Maintain up-to-date knowledge of FDA EU and global regulations and guidance relevant to marketed products
- Identify and communicate potential regulatory risks and mitigation strategies
- Lead or support a team of 2 to 4 regulatory professionals providing guidance and oversight on project execution
- Potentially contribute to pre-approval submissions (IND/CTA/IMPD) depending on experience
QUALIFICATIONS AND REQUIREMENTS:
Education:
- Bachelors or Masters degree in Pharmacy Biological Sciences Engineering or a related field. Advanced degree preferred
Experience:
- Minimum 7 years of experience in CMC post-approval regulatory submissions or related fields such as manufacturing quality control or analytical development
- At least 5 years of experience authoring and reviewing CMC sections in Modules 1 2 and 3 for post-approval filings
- Strong knowledge of US and European regulatory frameworks and ICH guidelines
- Experience in pharmaceutical development drug product specifications and stability programs
- Familiarity with cGMP environments and regulatory systems/tools (e.g. EDMS Veeva Vault Trackwise) is a plus
- Prior supervisory or team leadership experience is preferred
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
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 employees 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.
Required Experience:
Contract
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
The world’s leading CMC & Regulatory Affairs solutions provider for biopharma. Consulting solutions in CMC 360, global regulatory affairs & medical writing.
