Job Title:
Regulatory Consultant
Company:
Syneos Health
A global, integrated biopharmaceutical solutions organization that partners with pharmaceutical and biotech companies across clinical development and commercialization.
Location:
Gurugram, India (Hybrid, Asia-Pacific region)
Job ID:
25003301-IND002
Updated:
April 28, 2025
Job Summary:
The Regulatory Consultant independently manages regulatory activities and submissions for non-complex and complex projects globally. This includes preparing regulatory documents, ensuring compliance, supporting cross-functional teams, and contributing to business development.
Key Responsibilities:
Prepare and contribute to regulatory submissions including INDs, NDAs, MAAs, CTDs, and post-approval maintenance documentation.
Develop product development plans and gap analyses based on regulatory requirements.
Draft briefing packages and support regulatory meetings or scientific advice interactions.
Lead or support day-to-day regulatory operations for assigned projects within timelines and budgets.
Act as subject matter expert, troubleshoot issues, and guide project teams.
Participate in client meetings and proposal development.
Ensure compliance with global regulations and internal SOPs.
Provide training, develop best practices, and support audits and cross-functional initiatives.
Support change control assessments and Life Cycle Management (LCM) for Global ROW/EU submissions.
Qualifications:
Required:
BS or PhD in a science-related field (or equivalent regulatory/medical writing experience).
Proven experience in regulatory submissions such as INDs, NDAs, MAAs, CTDs (electronic format).
Fluent English communication skills, both written and spoken.
Strong attention to detail, adaptability, and ability to manage multiple projects.
Familiarity with regulatory documentation and lifecycle management.
Proficiency in Microsoft Office tools.
Preferred:
Experience with global LCM and post-approval submissions.
Knowledge of regulatory strategy and change control support.
About Syneos Health:
With operations in over 110 countries and involvement in 94% of novel FDA-approved drugs, Syneos Health is a trusted partner in clinical development. The company fosters innovation, diversity, and professional growth under its "Total Self" culture.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Kurla | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli |Odisha :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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China | Quarry Bay |Hubei :
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Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
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Croatia |Zagreb :
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Turku |France :
Paris | Lyon |Attica :
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Surabaya |Jakarta :
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Be'Er Sheva | Tel Aviv | Yavne | Netanya | Kfar Saba |Italy :
Italy |Lombardy :
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Remote - Africa | Melbourne | McFarland | Remote - Europe | Remote - South America (Latin Americal) | Lenexa | Remote, USA | Victoria | Remote | Remote - Middle East | Switzerland |Bucharest :
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Sweden |Taipei :
Taipei |Williamson :
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Ho Chi Minh City |