Specialist – Regulatory Affairs Manager
Job ID: 279902 | Location: Bangalore, Karnataka, India
Job Type: Full-time
About the Role:
As a Specialist – Regulatory Affairs Manager, you will be responsible for preparing dossiers and executing regulatory actions to ensure license security and product compliance in various markets. You will work in a matrix organization, collaborating with global stakeholders to navigate regulatory requirements and ensure compliance with health authorities’ guidelines.
Key Responsibilities:
Regulatory Documentation & License Management:
Prepare and manage regulatory dossiers, including full international submissions and large variations.
Support life-cycle management activities across at least two regions (e.g., Europe, USA, International).
Ensure compliance with regulatory guidelines, policies, and international regulations.
Interpret country-specific requirements and generate submission-ready deliverables.
Track and manage post-approval changes and regulatory dossier types.
Stakeholder Collaboration & Compliance:
Work in a matrix organization, collaborating with internal and external regulatory teams.
Support regulatory strategy discussions to align with business and compliance objectives.
Maintain regulatory intelligence and ensure timely documentation submission.
Proactively communicate potential risks and challenges to stakeholders.
Tools & Documentation Management:
Work with RIM, Vault, and EDMS RA applications for regulatory submissions.
Ensure documentation adheres to global regulatory standards.
Manage and track supportive documents (CPPs, GMP Certificates, MLs, AtO’s, AFs, CLs, PoAs, etc.).
Qualifications & Experience:
Education: MSc in Life Sciences, Pharmacy, or a related field.
Experience:
5+ years in a pharmaceutical regulatory environment (Competent Authority, Academia, R&D, or related fields).
Minimum 1 year of experience in Regulatory Affairs.
Skills & Competencies:
Strong understanding of global regulatory procedures.
Ability to review and interpret international regulatory guidelines.
Excellent project management and documentation skills.
Strong communication skills with fluency in English.
Detail-oriented with the ability to meet strict deadlines.
Why Join Us?
Work in a diverse and inclusive global environment.
Gain exposure to international regulatory processes.
Career development opportunities with continuous learning & growth.
Apply now and be part of a dynamic regulatory team!
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji | Verna |Gujarat :
Ahmedabad | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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 :
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Panjab :
Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Rangpo |Tamil Nadu :
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Birmingham |Alaska :
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Hilo | Honolulu |Idaho :
Boise |Illinois :
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Bangor | Brewer |Maryland :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
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Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
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China | Quarry Bay |Hubei :
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Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
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Remote Australia |Republic of Western Australia :
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Brussels |Flemish Brabant :
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Canada |Ontario :
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Japan |Tokyo :
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Remote Korea |Republic of Korea :
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Warsaw |Remote :
Remote - Africa | Remote - South America (Latin Americal) | Remote | Switzerland | Remote - Europe | Remote, USA | Remote - Middle East |Bucharest :
Bucharest |Makkah :
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Niš |Singapore :
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Midrand | South Africa |Brazil :
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Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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Dubai |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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